Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006224

CDR0000068144

GOG-0128F

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.

Full description

OBJECTIVES:

• Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols.
• Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. 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: Approximately 15-37 patients will be accrued for this study within 1 year.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable

  • Eligible subtypes:

    • Adenocarcinoma
    • Adenosquamous carcinoma
    • Undifferentiated carcinoma

  • Must have documented disease progression

  • Histologic confirmation of original primary tumor required

• Bidimensionally measurable disease

• Ineligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 100,000/mm^3
• Granulocyte count at least 1,500/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times normal
• SGOT and alkaline phosphatase no greater than 3 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• No significant infection
• Not pregnant
• Fertile patients must use effective contraception
• No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent filgrastim (G-CSF)

Chemotherapy:

• No prior gemcitabine
• At least 3 weeks since other prior chemotherapy for cervical cancer and recovered
• No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy)

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy for cervical cancer and recovered

Surgery:

• At least 3 weeks since prior surgery for cervical cancer and recovered

Other:

• No prior cancer treatment that would preclude study