Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
3 other identifiers
interventional
18
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2004
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 29, 2017
November 1, 2017
4.8 years
February 6, 2006
November 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose
Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
Up to 180 Days
Secondary Outcomes (2)
Response to Treatment
Up to 180 Days
Pharmacokinetics
Day 1 through Day 5
Study Arms (1)
Metronomic Docetaxel
EXPERIMENTALDocetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
- 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%
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Levi S. Downs, MD
Masonic Cancer Center, University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
March 1, 2004
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
November 29, 2017
Record last verified: 2017-11