Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring 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, stage IVB vaginal cancer, stage III vulvar cancer, recurrent vulvar cancer, stage IV vulvar cancer, ovarian sarcoma, ovarian stromal cancer, peritoneal cavity cancer
Eligibility Criteria
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 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Experimental
Metronomic Docetaxel
Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.