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

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00002949

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Bladder Cancer Cervical Cancer Endometrial Cancer Vaginal Cancer	Drug: paclitaxel Drug: vinorelbine tartrate Radiation: radiation therapy	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Study of Concomitant Chemoradiotherapy With Vinorelbine and Paclitaxel in Patients With Advanced Pelvic Malignancies

Study Start Date :

Jul 1, 1996

Actual Primary Completion Date :

Nov 1, 2000

Actual Study Completion Date :

May 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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