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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00006482

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: cisplatin Drug: gemcitabine hydrochloride	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Study Start Date :

Oct 1, 2000

Actual Primary Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	Rational Therapeutics Inc.	Long Beach	California	United States	90807
3	Community Hospital of Los Gatos	Los Gatos	California	United States	95032
4	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
5	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
6	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
7	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612
8	University of Illinois College of Medicine at Peoria	Peoria	Illinois	United States	61603
9	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
10	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
11	Tufts University School of Medicine	Boston	Massachusetts	United States	02111
12	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
13	Cooper Hospital/University Medical Center	Camden	New Jersey	United States	08103
14	Cancer Center of Albany Medical Center	Albany	New York	United States	12208
15	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
16	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
17	Schneider Children's Hospital at North Shore	Manhasset	New York	United States	11030
18	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
19	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
20	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
21	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
22	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45267-0502
23	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
24	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
25	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
26	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
27	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
28	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
29	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
30	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
31	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
32	Cancer Center at the University of Virginia	Charlottesville	Virginia	United States	22908
33	Tacoma General Hospital	Tacoma	Washington	United States	98405
34	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2