Cervical CancerPhase 1NCT01485731
Safety Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy to Treat Cervical Cancer
A Phase 1 study testing Nelfinavir, Cisplatin and Pelvic External Beam Radiation Therapy in people with Cervical Cancer, run by University of Miami at 1 site in United States.
Trial summary
Nelfinavir will increase the efficacy of Cisplatin based chemo- radiation therapy for locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Nelfinavir, Cisplatin and Pelvic External Beam Radiation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with primary, previously untreated, histologically confirmed invasive carcinoma of the uterine cervix (any cell type). Clinical stages IIA, IIB, IIIA, IIIB, IVA.
- Patients must have adequate bone marrow, renal and hepatic function:
- ANC ≥ 1,500/μL;
- Platelet count ≥ 100,000/μL;
- Creatinine < 2.0 mg/dL;
- Total Bilirubin ≤ 1.5 times normal;
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- SGOT ≤ 3 times normal.
- Patients with a GOG Performance Status of 0, 1, or 2.
- Patients with ureteral obstruction must be treated with stent or nephrostomy tube.
- Patients must be entered within eight weeks of diagnosis.
- Patients of childbearing potential must use an effective form of birth control."Patients receiving oral contraceptives should be instructed that alternate or additional contraceptive measures should be used during therapy with VIRACEPT. "
- Seronegative HIV status.
- Patients must be at least 18 years of age.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Who cannot join
- Patients with Stage IA, IB or IVB disease.
- Patients who have known metastases to other organs outside the radiation field at the time of the original clinical and surgical staging.
- Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy.
- Patients with septicemia or severe infection.
- Patients who have circumstances that will not permit completion of this study or the required follow-up.
- Patients who are pregnant at the time of diagnosis and do not wish pregnancy termination prior to initiation of treatment.
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- Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields.
- Patients with other concomitant malignancies (with the exception of non-melanoma skin cancer), who had (or have) any evidence of other cancer present within the last 5 years.
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- Patients with poorly controlled diabetes mellitus despite medication.
- Patients taking anti-arrhythmic agents such as amiodarone, quinidine, rifampin, ergot derivatives such as ergotamine, St Johs Wort, HMG-CoA reductase inhibitors such as lovastatin, neuroleptic such as pimozide, sedatives such as midazolam and triazolam among other CYP3A4 and CYP2C19 substrates.
- Patients with Phenylketonuria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)
Nelfinavir will increase the efficacy of Cisplatin based chemo- radiation therapy for locally advanced cervical cancer.
Read the detailed description
Despite cisplatin chemoradiation, 40-50% of women with locally advanced cervical cancer will die from their disease. The evaluation of new chemoradiation regimens have since included cisplatin to further build on its current success. In one year, Nelfinavir will be off patent and become a potential cost effective therapy. HIV Protease inhibitors are now being explored as potential therapies in oncology. The repositioning of HIV protease inhibitors, specifically nelfinavir in cancer therapeutics, is based on three facts. First, recent studies show that HIV protease inhibitors are established broad-spectrum anti-cancer agents that work through pleiotropic mechanisms such as by down-regulating activated mitogenic signaling pathways, and activating the immune response with Nelfinavir being the most potent [7]. Second, HIV protease inhibitors including nelfinavir can target specific viral antigens. Nelfinavir has been shown to target Human Papilloma Virus (HPV)-transformed cervical carcinoma cells via inhibition of E6-mediated proteosomal degradation of mutant p53 [8]. Thirdly, Nelfinavir has radiosensitizing properties through inhibiting the PI3K/Akt signaling pathway as demonstrated in vivo and in vitro in head and neck and pancreatic cancers models [9].
Nelfinavir is currently being evaluated as a radiosensitizer in head and neck and pancreatic cancers in phase I/II clinical trials. Brunner et al. (2008) recently completed the first phase I trial of nelfinavir added to chemoradiation for locally advanced pancreatic cancer [16]. Investigators treated 12 patients with advanced pancreatic carcinoma with Nelfinavir 1250 mg orally twice daily starting 3 days before radiation therapy and continued until the last day of radiation. They found no significant toxicity attributable to nelfinavir and observed a response rate of 50% versus 30% in historical controls. There were 5 of 12 patients with grade 3 hematologic toxicities (4 with leukopenia and 2 with thrombocytopenia). There were 3 of 12 patients with grade 3 GI toxicity (including abdominal pain, nausea, vomiting). There were no grade 4 drug related toxicities [16]. There were grade 1/ 2 toxicities including hematologic (thrombocytopenia, anemia, neutropenia), gastrointestinal toxicities (nausea, vomiting, diarrhea, abdominal pain), and elevated transaminases which were approximately 70%. Ten of 12 patients completed therapy. Complete responses were observed in 5 patients and partial responses were observed in 5 of 10 patients. Overall, the addition of Nelfinavir added minimal additional toxicity. Determination of a dose for biologic activity was not performed [14].
In summary, HIV protease inhibitors have a very broad spectrum of anti-tumor activity and can inhibit proliferation and/or cause death in the majority of cancer cell lines tested in a dose-dependent manner [7]. Nelfinavir has been found to be the most potent anti-tumor agent among the HIV protease inhibitors. As a result, several clinical trials are investigating Nelfinavir as a chemotherapeutic agent with and without concurrent radiation therapy in varied disease sites including rectal, head \& neck, glioblastomas, pancreas, renal cell, non-small cell lung cancer, liposarcoma, and gliomas. The NCI is also investigating Nelfinavir as single agent chemotherapy in advanced and recurrent solid tumors [15].
As Nelfinavir has both cytotoxic and radiation sensitizing effects, it is an ideal agent to use in combination with cisplatin-based chemoradiation in locally advanced cervical cancers.
In this study, patients with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral Nelfinavir (NFV) and weekly IV cisplatin in combination as radiosensitizers with daily whole pelvic external beam (Mon-Fri) followed by intracavitary radiation brachytherapy.
- Conditions
- Cervical Cancer
- Being tested
- Nelfinavir, Cisplatin, Pelvic External Beam Radiation Therapy, Brachytherapy, Pharmacokinetic Sampling
- Keywords
- Cervical, Cancer, Uterine Cervix, Squamous Cell, Adenocarcinoma
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelfinavirDrug
Also called NFV
Nelfinavir (NFV) will be prescribed orally twice daily for 7 days prior to initiation of cisplatin and pelvic radiation at the starting dose level, 875 mg BID
CisplatinDrug
Cisplatin at 40 mg/m2 (maximum total dose of 70 mg per week), will be infused intravenously once per week on either Day 1, 2, 3, 4, or 5 of weeks 2 to 6, preferably approximately four hours prior to radiation therapy. One additional cycle of cisplatin will be given either week 7 or 8 for a total of 6 cycles of cisplatin. Patients are not to be dosed more than 70 mg/week.
Pelvic External Beam Radiation TherapyRadiation
Also called PEBRT
Pelvic external beam radiation therapy (PEBRT) will be delivered in combination with weekly IV cisplatin (40mg/mg2) and twice daily oral NFV.PEBRT should be delivered once each day during the business week (Monday to Friday) according to the acceptable standards of care as prescribed by the treating radiation oncologist(s). The radiation therapy should consist of whole pelvic external beam radiation therapy (WPEBRT) with or without a parametrial boost (PB). PEBRT will be interdigitated with one administration of intrauterine brachytherapy (BT) given on any business day of week 7 or 8.
BrachytherapyRadiation
Also called BT
PEBRT will be interdigitated with one administration of intrauterine brachytherapy (BT) given on any business day of week 7 or 8.
Pharmacokinetic SamplingProcedure or surgery
Serum levels of Nelfinavir will be assayed at the following 3 time points: 5-8 days after initiation of NFV single agent (on Day 5, 6, or 7 of week 1 or day 1 of week 2), 1 week after combined NFV and cisplatin pelvic radiation (on day 15, 16, or 17 if start on Monday) for measurement of steady state, and at the completion of treatment (within the last 3 days of radiation in week 6). Blood samples will be taken before drug administration on the day of the sample to make sure the concentrations are actually at a minimum and before tumor biopsies.
Cervical BiopsyProcedure or surgery
Three punch biopsies of cervical tumor will be obtained during office visit at each time point (for PCR, IHC, and banked for future research). NFV serum levels will be obtained once NFV has been started (day 5-8 pre chemoradiation and at completion of chemoradiation) before each cervical biopsy
Pelvic ExaminationProcedure or surgery
Pre-Treatment, at the end of treatment +/- 1 week, every 3 months +/- 2 weeks after therapy (x 1 year)
Pap SmearProcedure or surgery
Recommended. Every 3 months +/- 2 weeks after therapy (x 1 year)
AudiogramProcedure or surgery
Required in patients with history of hearing loss; 28 days within starting treatment and every other cycle.
ProctoscopyProcedure or surgery
Optional. Pre-Treatment
CytoscopyProcedure or surgery
Optional. Pre-Treatment
Renal UltrasoundProcedure or surgery
Optional. Pre-Treatment
CT ScanProcedure or surgery
CT Scan of Chest/Abdomen/Pelvis, pre-treatment,Immediately at end of trial +/- 1 week, Every 3 months +/- 2 weeks after therapy (x 1 year)
Whole Body PET/CT ScanProcedure or surgery
In lieu of CT Scan, pre-treatment,Immediately at end of trial +/- 1 week, Every 3 months +/- 2 weeks after therapy (x 1 year)
| Study group | Role | What they receive |
|---|---|---|
| Nelfinavir + Cisplatin + Pelvic Radiation Therapy | Experimental | Nelfinavir in combination with Cisplatin and Pelvic Radiation Therapy Receives: Drug: Nelfinavir; Drug: Cisplatin; Radiation: Pelvic External Beam Radiation Therapy; Radiation: Brachytherapy; Procedure: Pharmacokinetic Sampling; Procedure: Cervical Biopsy; Procedure: Pelvic Examination; Procedure: Pap Smear; Procedure: Audiogram; Procedure: Proctoscopy; Procedure: Cytoscopy; Procedure: Renal Ultrasound; Procedure: CT Scan; Procedure: Whole Body PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Adverse Events in Phase 1 Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy
Number of Patients with Adverse Events in Phase 1 Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy
Measured: 3 Years
The proportion of enrolled patients for whom Nelfinavir dose can be successfully administered in combination with Cisplatin and Pelvic Radiation Therapy.
Maximum tolerable Phase II dose of Nelfinavir in combination with Cisplatin and Pelvic Radiation Therapy.
Measured: 3 Years
Secondary outcomes (4)
Serum Levels of Nelfinavir and other Biomarker Activity
To determine the levels of Akt activity (and downstream effectors such as pGSK3, pEBP1) and p16INK4A in addition to the presence of Human Papilloma Virus (HPV) 16 and18,and E6/E7 RNA in cervical biopsy specimens of patients at three different time points (1. pre-nelfinavir, pre-radiation, 2. while on nelfinavir, pre-radiation, 3. at completion of radiation therapy), and correlate the levels of these markers to serum Nelfinavir levels from blood drawn at the day of the biopsy.
Measured: 3 Years
Response to protocol therapy
Tumor response to protocol therapy will be measured using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Measured: 3 years
Progression-free Survival
Progression-Free Survival is the period from start of treatment until documented disease progression or death from any cause. For surviving patients without progression, progression-free survival will be censored at the last date of documented progression-free status.
Measured: 3 years
Overall Survival
Survival is the observed length of life from start of treatment to death. For surviving patients, follow-up will be censored at the date of last contact.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matt Pearson, University of Miami
- Investigators
- J. Matthew Pearson, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485731
- Sponsor's protocol ID
- 20100153
- Status last verified
- Jun 2015
- First submitted
- 29 Nov 2011
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)
- ClinicalTrials.gov ID
- NCT01485731
- Acronym / sponsor ID
- 20100153
- Conditions
- Cervical Cancer
- Keywords
- Cervical, Cancer, Uterine Cervix, Squamous Cell, Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nelfinavir will increase the efficacy of Cisplatin based chemo- radiation therapy for locally advanced cervical cancer.
Detailed description
Despite cisplatin chemoradiation, 40-50% of women with locally advanced cervical cancer will die from their disease. The evaluation of new chemoradiation regimens have since included cisplatin to further build on its current success. In one year, Nelfinavir will be off patent and become a potential cost effective therapy. HIV Protease inhibitors are now being explored as potential therapies in oncology. The repositioning of HIV protease inhibitors, specifically nelfinavir in cancer therapeutics, is based on three facts. First, recent studies show that HIV protease inhibitors are established broad-spectrum anti-cancer agents that work through pleiotropic mechanisms such as by down-regulating activated mitogenic signaling pathways, and activating the immune response with Nelfinavir being the most potent [7]. Second, HIV protease inhibitors including nelfinavir can target specific viral antigens. Nelfinavir has been shown to target Human Papilloma Virus (HPV)-transformed cervical carcinoma cells via inhibition of E6-mediated proteosomal degradation of mutant p53 [8]. Thirdly, Nelfinavir has radiosensitizing properties through inhibiting the PI3K/Akt signaling pathway as demonstrated in vivo and in vitro in head and neck and pancreatic cancers models [9].
Nelfinavir is currently being evaluated as a radiosensitizer in head and neck and pancreatic cancers in phase I/II clinical trials. Brunner et al. (2008) recently completed the first phase I trial of nelfinavir added to chemoradiation for locally advanced pancreatic cancer [16]. Investigators treated 12 patients with advanced pancreatic carcinoma with Nelfinavir 1250 mg orally twice daily starting 3 days before radiation therapy and continued until the last day of radiation. They found no significant toxicity attributable to nelfinavir and observed a response rate of 50% versus 30% in historical controls. There were 5 of 12 patients with grade 3 hematologic toxicities (4 with leukopenia and 2 with thrombocytopenia). There were 3 of 12 patients with grade 3 GI toxicity (including abdominal pain, nausea, vomiting). There were no grade 4 drug related toxicities [16]. There were grade 1/ 2 toxicities including hematologic (thrombocytopenia, anemia, neutropenia), gastrointestinal toxicities (nausea, vomiting, diarrhea, abdominal pain), and elevated transaminases which were approximately 70%. Ten of 12 patients completed therapy. Complete responses were observed in 5 patients and partial responses were observed in 5 of 10 patients. Overall, the addition of Nelfinavir added minimal additional toxicity. Determination of a dose for biologic activity was not performed [14].
In summary, HIV protease inhibitors have a very broad spectrum of anti-tumor activity and can inhibit proliferation and/or cause death in the majority of cancer cell lines tested in a dose-dependent manner [7]. Nelfinavir has been found to be the most potent anti-tumor agent among the HIV protease inhibitors. As a result, several clinical trials are investigating Nelfinavir as a chemotherapeutic agent with and without concurrent radiation therapy in varied disease sites including rectal, head \& neck, glioblastomas, pancreas, renal cell, non-small cell lung cancer, liposarcoma, and gliomas. The NCI is also investigating Nelfinavir as single agent chemotherapy in advanced and recurrent solid tumors [15].
As Nelfinavir has both cytotoxic and radiation sensitizing effects, it is an ideal agent to use in combination with cisplatin-based chemoradiation in locally advanced cervical cancers.
In this study, patients with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral Nelfinavir (NFV) and weekly IV cisplatin in combination as radiosensitizers with daily whole pelvic external beam (Mon-Fri) followed by intracavitary radiation brachytherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelfinavir + Cisplatin + Pelvic Radiation Therapy | Experimental | Drug: Nelfinavir, Drug: Cisplatin, Radiation: Pelvic External Beam Radiation Therapy, Radiation: Brachytherapy, Procedure: Pharmacokinetic Sampling, Procedure: Cervical Biopsy, Procedure: Pelvic Examination, Procedure: Pap Smear, Procedure: Audiogram, Procedure: Proctoscopy, Procedure: Cytoscopy, Procedure: Renal Ultrasound, Procedure: CT Scan, Procedure: Whole Body PET/CT ScanNelfinavir in combination with Cisplatin and Pelvic Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- All patients with primary, previously untreated, histologically confirmed invasive carcinoma of the uterine cervix (any cell type). Clinical stages IIA, IIB, IIIA, IIIB, IVA.
- Patients must have adequate bone marrow, renal and hepatic function:
- Patients with a GOG Performance Status of 0, 1, or 2.
- Patients with ureteral obstruction must be treated with stent or nephrostomy tube.
- Patients must be entered within eight weeks of diagnosis.
Key exclusion criteria (12 listed)
- Patients with Stage IA, IB or IVB disease.
- Patients who have known metastases to other organs outside the radiation field at the time of the original clinical and surgical staging.
- Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy.
- Patients with septicemia or severe infection.
- Patients who have circumstances that will not permit completion of this study or the required follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NelfinavirAlso: NFVNelfinavir (NFV) will be prescribed orally twice daily for 7 days prior to initiation of cisplatin and pelvic radiation at the starting dose level, 875 mg BID | Drug | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| CisplatinCisplatin at 40 mg/m2 (maximum total dose of 70 mg per week), will be infused intravenously once per week on either Day 1, 2, 3, 4, or 5 of weeks 2 to 6, preferably approximately four hours prior to radiation therapy. One additional cycle of cisplatin will be given either week 7 or 8 for a total of 6 cycles of cisplatin. Patients are not to be dosed more than 70 mg/week. | Drug | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| Pelvic External Beam Radiation TherapyAlso: PEBRTPelvic external beam radiation therapy (PEBRT) will be delivered in combination with weekly IV cisplatin (40mg/mg2) and twice daily oral NFV.PEBRT should be delivered once each day during the business week (Monday to Friday) according to the acceptable standards of care as prescribed by the treating radiation oncologist(s). The radiation therapy should consist of whole pelvic external beam radiation therapy (WPEBRT) with or without a parametrial boost (PB). PEBRT will be interdigitated with one administration of intrauterine brachytherapy (BT) given on any business day of week 7 or 8. | Radiation | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| BrachytherapyAlso: BTPEBRT will be interdigitated with one administration of intrauterine brachytherapy (BT) given on any business day of week 7 or 8. | Radiation | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| Pharmacokinetic SamplingSerum levels of Nelfinavir will be assayed at the following 3 time points: 5-8 days after initiation of NFV single agent (on Day 5, 6, or 7 of week 1 or day 1 of week 2), 1 week after combined NFV and cisplatin pelvic radiation (on day 15, 16, or 17 if start on Monday) for measurement of steady state, and at the completion of treatment (within the last 3 days of radiation in week 6). Blood samples will be taken before drug administration on the day of the sample to make sure the concentrations are actually at a minimum and before tumor biopsies. | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| Cervical BiopsyThree punch biopsies of cervical tumor will be obtained during office visit at each time point (for PCR, IHC, and banked for future research). NFV serum levels will be obtained once NFV has been started (day 5-8 pre chemoradiation and at completion of chemoradiation) before each cervical biopsy | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| Pelvic ExaminationPre-Treatment, at the end of treatment +/- 1 week, every 3 months +/- 2 weeks after therapy (x 1 year) | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| Pap SmearRecommended. Every 3 months +/- 2 weeks after therapy (x 1 year) | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| AudiogramRequired in patients with history of hearing loss; 28 days within starting treatment and every other cycle. | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| ProctoscopyOptional. Pre-Treatment | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| CytoscopyOptional. Pre-Treatment | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| Renal UltrasoundOptional. Pre-Treatment | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| CT ScanCT Scan of Chest/Abdomen/Pelvis, pre-treatment,Immediately at end of trial +/- 1 week, Every 3 months +/- 2 weeks after therapy (x 1 year) | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
| Whole Body PET/CT ScanIn lieu of CT Scan, pre-treatment,Immediately at end of trial +/- 1 week, Every 3 months +/- 2 weeks after therapy (x 1 year) | Procedure or surgery | Nelfinavir + Cisplatin + Pelvic Radiation Therapy |
Primary outcome
Number of Patients with Adverse Events in Phase 1 Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy
Time frame: 3 Years
Number of Patients with Adverse Events in Phase 1 Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy
The proportion of enrolled patients for whom Nelfinavir dose can be successfully administered in combination with Cisplatin and Pelvic Radiation Therapy.
Time frame: 3 Years
Maximum tolerable Phase II dose of Nelfinavir in combination with Cisplatin and Pelvic Radiation Therapy.
4 secondary outcomes
Serum Levels of Nelfinavir and other Biomarker Activity
Time frame: 3 Years
Response to protocol therapy
Time frame: 3 years
Progression-free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Matthew Pearson, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nelfinavir, Cisplatin and Pelvic External Beam Radiation Therapy in people with Cervical Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Adverse Events in Phase 1 Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy (time frame: 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.