Locally Advanced Cervical CancerPhase 1PHOENIX INCT01217177
A Study of mTOR Inhibitor Everolimus (RAD001) in Association With Cisplatin and Radiotherapy for Locally Advanced Cervix Cancer
A Phase 1 study testing everolimus in people with Locally Advanced Cervical Cancer, run by Novartis Pharmaceuticals at 2 sites in Brazil.
Trial summary
The cervix cancer is the second malignant neoplasia more common between women. The combined treatment involving chemotherapy and radiotherapy was defined as the standard. This study will evaluate the safety, toxicity and maximal tolerated dose (MTD) of everolimus in association with cisplatin and pelvic radiotherapy… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesBrazil
- Study dates
- Dec 2011to Apr 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ECOG performance of 0, 1 or 2.
- Evidence of measurable disease of unidimensional form.
- Epidermoid carcinoma confirmed by histological examination of cervix, stages IIB to IIIB (according to clinical and radiological evaluation), without previous treatment. Absence of positive paraaortic lymph nodes at PET (Positron Emission Tomography).
- Adequate function of organ, according to following criteria:
- Serum levels of aspartate aminotransferase (ASAT/AAT/AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (Upper Limit of Normal)
- Total serum bilirubin ≤1.5 ULN
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- Absolute neutrophils counting ≥1.500/mm3
- Platelet counting ≥100.000/mm3
- Hemoglobin ≥10.0 g/dL
- Serum calcium ≤12.0 mg/dL
- Serum creatinine ≤1.5 x ULN and estimate creatinine clearance (Cockroft-Gault) ≥60 mL/min
- Prothrombin time ≤1.5 x ULN Obs.: The serum levels of potassium, magnesium, sodium and calcium outside normality range should be corrected before the administration of the first dose of investigational product.
- Patients with at least one measurable lesion in the baseline period, according to criteria RECIST, version 1.1.
- Adequate lipid profile: total cholesterol <300 mg/dL and triglycerides <200 mg/dL.
- Willingness to follow the treatment plan, scheduled visits, laboratory and radiological examinations, as well as other procedures.
- Signed and dated informed consent form, indicating that the patient (or his/her representative) has received information about all relevant study aspects, before his/her inclusion.
- Women with possibility to become pregnant should present a negative serum examination for pregnancy, done within the period of 7 days before the administration of study treatment; and should be willing to use a contraceptive method along the entire study, and for 3 months after the last administration of investigational drug.
Who cannot join
- Major surgery <4 weeks before study treatment starting.
- Any malignant neoplasia in the last 5 years, except for adequately treated melanoma skin cancer.
- Metastases in the initial diagnostic evaluation [thorax and abdomen computerized tomography (with contrast), pelvis magnetic resonance and PET scanning].
- Occurrence of some of the following events, during the period of 12 months previously to study medication administration: unstable angina pectoris, symptomatic congestive heart failure (II, III, IV of NYHA), myocardium infarction, severe uncontrolled cardiac arrhythmia, cerebrovascular accident.
- Positive serology for HIV infection.
- Patients with positive examinations for hepatitis B (HBsAg, anti-HBs without previous vaccination against HBV and anti-HBc) and hepatitis C (HCV RNA detectable by PCR).
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- Any psychologic, familial, social or geographic problem that could embarrass the adhesion to protocol and study scheme.
- Patients using other agents under investigation or receiving investigational medications ≤4 weeks before the study treatment starting.
- Patients presenting some severe and/or uncontrolled medical problem, or other disturbances that could affect their participation in the study, such as, for instance:
- Unstable angina pectoris, symptomatic congestive heart failure (II, III, IV of NYHA), myocardial infarction ≤12 months before the first administration of study medication, severe uncontrolled cardiac arrhythmia, cerebrovascular accident ≤12 months before the starting of study medication administration;
- Severely compromised pulmonary function defined by spirometry with 50% of anticipated normal value or decompensated pulmonary disease.
- Uncontrolled diabetes satisfactorily defined by a fast glycemia result >2.0 x ULN;
- Any active or uncontrolled disease/infection (acute or chronic) compromising the patient evaluation capability or impeding him/her to complete the study.
- Hepatic disease with cirrhosis, decompensated hepatic disease, active chronic hepatitis, or persistent chronic hepatitis.
- Compromising of gastrointestinal (GI) function, or GI disease that could significantly alter the everolimus absorption.
- Patients unwilling or unable to accomplish the protocol requirements.
- Hypersensitivity to everolimus or any of its excipients, or to other rapamycins (for instance: sirolimus, temsirolimus).
- Patients receiving systemic immunosuppressive agents chronically. Inhaling or topic corticosteroids are acceptable. The patients should be receiving stable chronic (not increased within the last month) doses of corticosteroids, with the maximal dose corresponding to 20 mg de prednisone or 10 mg of dexamethasone per day.
- Pregnant (that is, having positive examination for beta human chorionic gonadotropin) or lactating women.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20230-130
Novartis Investigative Site
Rio de Janeiro
About this study
Official title: A Phase I Study of Oral Administration of mTOR Inhibitor Everolimus (RAD001) in Association With Cisplatin and Radiotherapy for the Treatment of Locally Advanced Cervix Cancer
The cervix cancer is the second malignant neoplasia more common between women. The combined treatment involving chemotherapy and radiotherapy was defined as the standard. This study will evaluate the safety, toxicity and maximal tolerated dose (MTD) of everolimus in association with cisplatin and pelvic radiotherapy, in patients with squamous cells carcinoma of uterine cervix, in stages IIB and IIIB.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- everolimus
- Keywords
- Cervical cancer,, radiotherapy,, chemotherapy,, rad001,, everolimus
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
Also called RAD001
| Study group | Role | What they receive |
|---|---|---|
| 2.5 mg everolimus + radiotherapy + cisplatin | Experimental | patients treated with daily doses of everolimus (2.5mg) in association with radiotherapy and cisplatin (40 mg/m2 of body surface per week, 5 cycles during radiotherapy) Receives: Drug: everolimus |
| 5.0 mg everolimus + radiotherapy + cisplatin | Experimental | patients treated with daily doses of everolimus (5.0mg) in association with radiotherapy and cisplatin (40 mg/m2 of body surface per week, 5 cycles during radiotherapy) Receives: Drug: everolimus |
| 10 mg everolimus + radiotherapy + cisplatin | Experimental | patients treated with daily doses of everolimus (10mg) in association with radiotherapy and cisplatin (40 mg/m2 of body surface per week, 5 cycles during radiotherapy) Receives: Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The toxicity criteria will be evaluated according to National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 3.0.
Measured: 12 month
Secondary outcomes (1)
The objective response rate will be evaluated according to clinical/gynecological examination and inconformity with the RECIST criteria (Response Evaluation Criteria in Solid Tumors, version 1.1)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startDec 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217177
- Sponsor's protocol ID
- CRAD001C24128
- Acronym
- PHOENIX I
- Status last verified
- Apr 2015
- First submitted
- 6 Oct 2010
- Last updated
- 3 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Oral Administration of mTOR Inhibitor Everolimus (RAD001) in Association With Cisplatin and Radiotherapy for the Treatment of Locally Advanced Cervix Cancer
- ClinicalTrials.gov ID
- NCT01217177
- Acronym / sponsor ID
- PHOENIX I / CRAD001C24128
- Conditions
- Locally Advanced Cervical Cancer
- Keywords
- Cervical cancer,, radiotherapy,, chemotherapy,, rad001,, everolimus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Oct 2010 (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.
The cervix cancer is the second malignant neoplasia more common between women. The combined treatment involving chemotherapy and radiotherapy was defined as the standard. This study will evaluate the safety, toxicity and maximal tolerated dose (MTD) of everolimus in association with cisplatin and pelvic radiotherapy, in patients with squamous cells carcinoma of uterine cervix, in stages IIB and IIIB.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2.5 mg everolimus + radiotherapy + cisplatin | Experimental | Drug: everolimuspatients treated with daily doses of everolimus (2.5mg) in association with radiotherapy and cisplatin (40 mg/m2 of body surface per week, 5 cycles during radiotherapy) |
| 5.0 mg everolimus + radiotherapy + cisplatin | Experimental | Drug: everolimuspatients treated with daily doses of everolimus (5.0mg) in association with radiotherapy and cisplatin (40 mg/m2 of body surface per week, 5 cycles during radiotherapy) |
| 10 mg everolimus + radiotherapy + cisplatin | Experimental | Drug: everolimuspatients treated with daily doses of everolimus (10mg) in association with radiotherapy and cisplatin (40 mg/m2 of body surface per week, 5 cycles during radiotherapy) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- ECOG performance of 0, 1 or 2.
- Evidence of measurable disease of unidimensional form.
- Epidermoid carcinoma confirmed by histological examination of cervix, stages IIB to IIIB (according to clinical and radiological evaluation), without previous treatment. Absence of positive paraaortic lymph nodes at PET (Positron Emission Tomography).
- Adequate function of organ, according to following criteria:
- Patients with at least one measurable lesion in the baseline period, according to criteria RECIST, version 1.1.
Key exclusion criteria (20 listed)
- Major surgery <4 weeks before study treatment starting.
- Any malignant neoplasia in the last 5 years, except for adequately treated melanoma skin cancer.
- Metastases in the initial diagnostic evaluation [thorax and abdomen computerized tomography (with contrast), pelvis magnetic resonance and PET scanning].
- Occurrence of some of the following events, during the period of 12 months previously to study medication administration: unstable angina pectoris, symptomatic congestive heart failure (II, III, IV of NYHA), myocardium infarction, severe uncontrolled cardiac arrhythmia, cerebrovascular accident.
- Positive serology for HIV infection.
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 |
|---|---|---|
| everolimusAlso: RAD001 | Drug | 10 mg everolimus + radiotherapy + cisplatin, 2.5 mg everolimus + radiotherapy + cisplatin, 5.0 mg everolimus + radiotherapy + cisplatin |
Primary outcome
The toxicity criteria will be evaluated according to National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 3.0.
Time frame: 12 month
1 secondary outcome
The objective response rate will be evaluated according to clinical/gynecological examination and inconformity with the RECIST criteria (Response Evaluation Criteria in Solid Tumors, version 1.1)
Time frame: 12 month
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 Apr 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing everolimus in people with Locally Advanced Cervical Cancer, run by Novartis Pharmaceuticals at 2 sites in Brazil.
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 17 inclusion and 20 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 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
The toxicity criteria will be evaluated according to National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 3.0. (time frame: 12 month). 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 Apr 2015.