Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: gemcitabine hydrochloride; Drug: cisplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006482

GOG-0127Q

CDR0000068313

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. Combining more than one drug may kill more tumor cells.

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

Full description

OBJECTIVES:

• Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix.
• Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days 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 28-69 patients will be accrued for this study.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable

• Must have had 1 prior chemotherapy regimen for cervical cancer

  • No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer
  • No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy

• Bidimensionally measurable disease

• Ineligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least lower limit of normal
• Absolute neutrophil 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 2.0 mg/dL

Other:

• Not pregnant
• Fertile patients must use effective contraception
• No significant infection
• No other malignancies within past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic therapy for cervical cancer

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy for cervical cancer and recovered
• No prior gemcitabine

Endocrine therapy:

• At least 3 weeks since prior endocrine therapy for cervical cancer

Radiotherapy:

• At least 3 weeks since prior radiotherapy for cervical cancer and recovered
• No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

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

Other:

• No concurrent amifostine or other protective reagents
• No prior anticancer therapy that contraindicates study