RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy with may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy with vinorelbine and paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the pelvis.

Condition	Treatment or Intervention	Phase
stage III bladder cancer stage III endometrial cancer stage II bladder cancer stage II cervical cancer stage III cervical cancer stage IV cervical cancer stage IVB vaginal cancer stage IV bladder cancer stage IV endometrial cancer stage III vaginal cancer stage IVA vaginal cancer stage II endometrial cancer stage II vaginal cancer	Drug: paclitaxel  Drug: vinorelbine	Phase I

Further Study Details: 

OBJECTIVES: I. Assess the toxic effects of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation therapy.

II. Determine the Maximum Tolerated Dose (MTD) of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation therapy.

III. Access the toxic effects of paclitaxel given weekly in combination with the regimen determined to be the MTD of vinorelbine.

IV. Determine the MTD of paclitaxel given weekly in combination with the regimen determined to be the MTD of vinorelbine.

PROTOCOL OUTLINE: Part I: Vinorelbine IV bolus is administered over 8-10 minutes on day 1 prior to radiation therapy. Whole pelvic radiation treatment is given on days 1-5 followed by 2 days of rest. The treatment volume encompasses all suspected pelvic disease with a minimum of 1 cm margin. Cycles repeat weekly.

Dose of vinorelbine is escalated in cohorts of at least 3 patients until maximum tolerated dose (MTD) is determined.

Part II: Paclitaxel is infused over 1 hour immediately following vinorelbine at the MTD, as determined in part I.

Dose of paclitaxel is escalated in cohorts of at least 3 patients until the MTD is determined.

At least 6 patients are treated at the MTD for both parts I and II of the study. Patients are followed for late and chronic toxicities.

PROJECTED ACCRUAL: Projected accrual is 12 patients per year for approximately 3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed locally advanced carcinoma of the uterine cervix, vagina, or bladder or other pelvic malignancy for which whole pelvic radiation therapy is planned
• Metastatic disease is permitted

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior whole pelvic radiation therapy
• Surgery: Not specified

--Patient Characteristics--

• Age: Over 18
• Performance status: CALGB 0-2
• Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin within normal limits
• Renal: Creatinine no greater than 2.5 mg/dL
• Cardiovascular: No unstable angina or myocardial infarction in previous 6 months
• Other: Not pregnant; No significant concomitant illness, uncontrolled infection, or cirrhosis

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States

Study chairs or principal investigators

Gini F. Fleming,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000065417; UCCRC-8270; NCI-G97-1156
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002949
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08