Clinical Trial: Vinorelbine and Paclitaxel Plus Radiation Therapy in Treating Patients With Advanced Cancer Arising in the Pelvis

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
University of Chicago Cancer Research Center
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Bladder Cancer;   Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Male Genital Disorders;   Reproductive Health;   Uterine Cancer;   Vaginal Cancer
Genetics Home Reference related topics:  bladder cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Concomitant Chemoradiotherapy with Vinorelbine and Paclitaxel in Patients with Advanced Pelvic Malignancies

Further Study Details: 

Study start: July 1996

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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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