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A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX


OBJECTIVES: I. Determine the activity of cisplatin and vinorelbine in terms of response
rate, duration of response, time to treatment failure, and survival in patients with
advanced, persistent, or recurrent squamous cell carcinoma of the cervix.

OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes on
days 1, 8, 15, and 22 and cisplatin IV over 4 hours beginning after completion of
vinorelbine infusion on day 1. Courses repeat every 4 weeks in the absence of disease
progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within
approximately 20 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven advanced, persistent, or recurrent squamous
cell carcinoma of the cervix that failed local therapy and is considered incurable
Bidimensionally measurable abdominal, pelvic, or other lesion by palpation, x- ray, or
ultrasound If sole site of measurable disease previously irradiated, then documented
disease progression at that site required

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Karnofsky 60%-100%
Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater
than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine
no greater than 1.4 mg/dL Creatinine clearance at least 50 mL/min if creatinine greater
than 1.2 mg/dL Other: No clinically significant infection No preexisting, clinically
significant peripheral neuropathy unless due to cancer No other prior or concurrent
malignancy except nonmelanomatous skin cancer No psychological, familial, sociological, or
geographical condition that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy except for radiosensitization Endocrine therapy: Not specified Radiotherapy:
See Chemotherapy Recovered from the toxic effects of any recent radiotherapy Surgery:
Recovered from the toxic effects of any recent surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mitchell Morris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064956

NCT ID:

NCT00002813

Start Date:

August 1997

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • cervical squamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Chao Family Comprehensive Cancer CenterOrange, California  92868
MBCCOP - HawaiiHonolulu, Hawaii  96813
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Cancer Center of Albany Medical CenterAlbany, New York  12208
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Brookview Research, Inc.Nashville, Tennessee  37203