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


Phase 1
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Cervical Cancer, Endometrial Cancer, Vaginal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Gini F. Fleming, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

8270

NCT ID:

NCT00002949

Start Date:

July 1996

Completion Date:

May 2001

Related Keywords:

  • Bladder Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Vaginal Cancer
  • 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 endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • stage II bladder cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • Urinary Bladder Neoplasms
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Adenoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637