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

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Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated dose


Condition

Bladder Cancer

Intervention

paclitaxel

Study Arms / Comparison Groups

 Arm A
Description:  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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

July 1996

Completion Date

May 2001

Primary Completion Date

November 2000

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gini F. Fleming, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00002949

Organization ID

8270

Secondary IDs

UCCRC-8270

Responsible Party

Sponsor

Study Sponsor

University of Chicago

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Gini F. Fleming, MD, Study Chair, University of Chicago


Verification Date

September 2013