Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002562

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

125

Duration (Months)

0.5

Patients Per Site

Patients Per Site Per Month

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.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Vaginal Cancer	Drug: paclitaxel	Phase 2

Detailed Description

OBJECTIVES: I. Estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols. II. Determine the frequency and severity of observed adverse effects on this study.

OUTLINE: Single-Agent Chemotherapy. Paclitaxel, TAX, NSC-673089.

PROJECTED ACCRUAL: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. If more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. As of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Primary Purpose:

Treatment

Official Title:

EVALUATION OF PACLITAXEL (TAXOL) IN PERSISTENT OR RECURRENT NON-SQUAMOUS CELL CARCINOMA OF THE CERVIX AND VAGINA

Study Start Date :

Mar 1, 1994

Actual Study Completion Date :

Aug 1, 2004

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 advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina or cervix Documented disease progression after local therapy required Disease must be considered incurable Bidimensionally measurable disease required by physical examination or medical imaging

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no more than 1.5 times normal AST no more than 3 times normal Alkaline phosphatase no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Other: Not eligible for a higher priority GOG protocol No significant infection No prior or concomitant second malignancy except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: At least 3 weeks since therapy directed at malignancy Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen (either single or combination cytotoxic drug therapy) No prior paclitaxel Recovery from prior chemotherapy required Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent disease except a low dose, single fraction used to abrogate menorrhagia Recovery from prior radiotherapy required Surgery: Recovery from prior surgery required

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033-0800
3	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
4	Women's Cancer Center	Palo Alto	California	United States	94304
5	Stanford University Medical Center	Stanford	California	United States	94305-5408
6	University of Colorado Cancer Center	Denver	Colorado	United States	80262
7	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia	United States	20007
8	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
9	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
10	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
11	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
12	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612
13	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
14	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5265
15	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
16	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
17	Johns Hopkins Oncology Center	Baltimore	Maryland	United States	21287
18	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
19	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
20	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
21	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
22	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
23	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
24	Cooper Hospital/University Medical Center	Camden	New Jersey	United States	08103
25	Cancer Center of Albany Medical Center	Albany	New York	United States	12208
26	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
27	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
28	University of Rochester Cancer Center	Rochester	New York	United States	14642
29	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York	United States	11790-9832
30	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
31	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
32	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1082
33	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45219
34	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
35	Cleveland Clinic Cancer Center	Cleveland	Ohio	United States	44195
36	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210
37	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
38	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
39	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
40	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
41	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107
42	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
43	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
44	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
45	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
46	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
47	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030
48	Cancer Center, University of Virginia HSC	Charlottesville	Virginia	United States	22908
49	University of Washington Medical Center	Seattle	Washington	United States	98195-6043
50	Tacoma General Hospital	Tacoma	Washington	United States	98405