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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00002949
First received: November 1, 1999
Last updated: September 4, 2013
Last verified: September 2013
  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 Intervention Phase
Bladder Cancer
Cervical Cancer
Endometrial Cancer
Vaginal Cancer
Drug: paclitaxel
Drug: vinorelbine tartrate
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Concomitant Chemoradiotherapy With Vinorelbine and Paclitaxel in Patients With Advanced Pelvic Malignancies

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: July 1996
Study Completion Date: May 2001
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Vinorelbine (qwk, 10, 15, 20 or 25 mg/m2), Radiation therapy (Total pelvic RT of 45 Gy in 1.8-Gy daily fractions, 85 Gy in cervical cancer patients using intracavitary brachytherapy, 70 Gy in patients treated with interstitial brachytherapy) Paclitaxel (qwk, starting dose of 20mg/m2 with planned dose escalation increments of 5mg/m2)
Drug: paclitaxel
Paclitaxel (qwk, starting dose of 20mg/m2 with planned dose escalation increments of 5mg/m2)
Drug: vinorelbine tartrate
Vinorelbine (qwk, 10, 15, 20 or 25 mg/m2),
Radiation: radiation therapy
Radiation therapy (Total pelvic RT of 45 Gy in 1.8-Gy daily fractions, 85 Gy in cervical cancer patients using intracavitary brachytherapy, 70 Gy in patients treated with interstitial brachytherapy)

Detailed Description:

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.

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002949

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Gini F. Fleming, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00002949     History of Changes
Other Study ID Numbers: 8270, UCCRC-8270, NCI-G97-1156
Study First Received: November 1, 1999
Last Updated: September 4, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
stage II cervical cancer
stage III cervical cancer
stage IV cervical cancer
stage II vaginal cancer
stage III vaginal cancer
stage IVA vaginal cancer
stage IVB vaginal cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Vaginal Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Vaginal Diseases
Urinary Bladder Diseases
Urologic Diseases
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Vinorelbine
Vinblastine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014