Trial | NCT00006482  Report issue

Title

Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    None
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.
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.
Study Started
Oct 31
2000
Primary Completion
Apr 30
2006
Last Update
Apr 11
2013
Estimate

Drug cisplatin

Drug gemcitabine hydrochloride

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
No Results Posted