Cervical CancerPhase 1NCT00287885
Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
A Phase 1 study testing docetaxel in people with Cervical Cancer and Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
- What is being tested?
- docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Dec 2008
- 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
- Patients must have histologically confirmed advanced, refractory gynecologic cancer.
- Patients must have received prior chemotherapy, and must have residual or recurrent disease after initial therapy or after subsequent therapy.
- Patients must have at least one site of bi-dimensional measurable disease as defined in section 9 or must have evaluable but radiographically non-measurable disease associated with CA-125 > 50 units/ml on two measurements at least one week apart. Baseline measurements and CA-125 must be obtained for all patients within four weeks before registration.
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients must not have received any hormonal or immunologic therapy for 2 weeks or cytotoxic chemotherapy or radiation therapy for 4 weeks (nitrosoureas and mitomycin C require 6 weeks) prior to registration.
- Patients may not have a history of prior malignancy in the past 5 years other than non-melanoma skin cancer or in situ carcinoma of the cervix.
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- Patients must have documented adequate organ function within 4 weeks of registration defined as:
- Marrow: WBC ≥ 3000/mm3, ANC ≥ 1500/mm3 , Hgb ≥ 8.0 g/dl, platelets ≥ 100,000/mm3
- Hepatic: Total Bilirubin ≤ ULN, SGOT or SGPT and Alkaline Phosphatase must be within the range allowing for eligibility, as in the table below
- SGOT or SGPT: Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND SGOT or SGPT normal
- AP ≤ 5 times ULN AND SGOT or SGPT normal
- AP normal AND SGOT or SGPT ≤ 5 times ULN
- AP ≤ 2.5 ULN AND SGOT or SGPT ≤ 1.5 times ULN
- Renal: BUN ≤ 30 mg%, creatinine ≤ 1.5 mg%
- Age ≥ 18 years
Who cannot join
- Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk.
- Patients of reproductive potential must use effective birth control, preferably with barrier methods.
- Prior history of myocardial infarction, congestive heart failure or significant ischemic or valvular heart disease.
- Patients with known brain metastases are not eligible.
- Peripheral neuropathy must be ≤ grade 2.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
- Patient must given written informed consent indicating the investigational nature of the treatment and its potential risks
About this study
Official title: Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving daily doses of docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel in treating patients with refractory or recurrent advanced gynecologic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine the pharmacokinetics associated with this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel intravenously (IV) over 1-2 minutes daily for up to 6 months in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months.
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer, Sarcoma
- Being tested
- docetaxel
- Keywords
- recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, stage III endometrial carcinoma, recurrent endometrial carcinoma, stage IV endometrial carcinoma, fallopian tube cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage III ovarian germ cell tumor, recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, recurrent ovarian epithelial cancer, recurrent uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, stage III vaginal cancer, recurrent vaginal cancer, stage IVA vaginal cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Sarcoma, Vaginal Neoplasms, Vulvar Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called Taxotere
Three patients will be enrolled and dosed at each level; from dose level 1 of 2.9 mg/m^2/day up to dose level 6 of 6.4 mg/m^2/day
| Study group | Role | What they receive |
|---|---|---|
| Metronomic Docetaxel | Experimental | Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port. Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
Measured: Up to 180 Days
Secondary outcomes (2)
Response to Treatment
Determine the response rate in patients treated with this drug.
Measured: Up to 180 Days
Pharmacokinetics
Determine the pharmacokinetics associated with this drug in these patients.
Measured: Day 1 through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startMar 2004
- Primary completionDec 2008
- Study completionDec 2008
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 Masonic Cancer Center, University of MinnesotaThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Levi S. Downs, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287885
- Sponsor's protocol ID
- 2003LS034
- Other IDs
- UMN-WCC-35, 0307M50626
- Status last verified
- Nov 2017
- First submitted
- 6 Feb 2006
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT00287885
- Acronym / sponsor ID
- 2003LS034
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer, Sarcoma
- Keywords
- recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, stage III endometrial carcinoma, recurrent endometrial carcinoma, stage IV endometrial carcinoma, fallopian tube cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Feb 2006 (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.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving daily doses of docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel in treating patients with refractory or recurrent advanced gynecologic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine the pharmacokinetics associated with this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel intravenously (IV) over 1-2 minutes daily for up to 6 months in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metronomic Docetaxel | Experimental | Drug: docetaxelDocetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically confirmed advanced, refractory gynecologic cancer.
- Patients must have received prior chemotherapy, and must have residual or recurrent disease after initial therapy or after subsequent therapy.
- Patients must have at least one site of bi-dimensional measurable disease as defined in section 9 or must have evaluable but radiographically non-measurable disease associated with CA-125 > 50 units/ml on two measurements at least one week apart. Baseline measurements and CA-125 must be obtained for all patients within four weeks before registration.
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients must not have received any hormonal or immunologic therapy for 2 weeks or cytotoxic chemotherapy or radiation therapy for 4 weeks (nitrosoureas and mitomycin C require 6 weeks) prior to registration.
Key exclusion criteria (7 listed)
- Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk.
- Patients of reproductive potential must use effective birth control, preferably with barrier methods.
- Prior history of myocardial infarction, congestive heart failure or significant ischemic or valvular heart disease.
- Patients with known brain metastases are not eligible.
- Peripheral neuropathy must be ≤ grade 2.
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 |
|---|---|---|
| docetaxelAlso: TaxotereThree patients will be enrolled and dosed at each level; from dose level 1 of 2.9 mg/m^2/day up to dose level 6 of 6.4 mg/m^2/day | Drug | Metronomic Docetaxel |
Primary outcome
Maximum Tolerated Dose
Time frame: Up to 180 Days
Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
2 secondary outcomes
Response to Treatment
Time frame: Up to 180 Days
Pharmacokinetics
Time frame: Day 1 through Day 5
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 29 Nov 2017.
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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.
Levi S. Downs, MD study chair
Masonic Cancer Center, University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing docetaxel in people with Cervical Cancer and Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota.
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 16 inclusion and 7 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 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum Tolerated Dose (time frame: Up to 180 Days). 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 29 Nov 2017.