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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

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