Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer (NCT00287885) | Clinical Trial Compass
CompletedPhase 1
Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
18 participantsStarted 2004-03
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 norma…
What they're measuring
1
Maximum Tolerated Dose
Timeframe: Up to 180 Days
Trial details
NCT IDNCT00287885
SponsorMasonic Cancer Center, University of Minnesota