Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003379

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

1.3

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy to the pelvis plus paclitaxel and cisplatin in treating patients who have cervical cancer.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: cisplatin Drug: paclitaxel Radiation: brachytherapy Radiation: radiation therapy	Phase 1/Phase 2

Detailed Description

OBJECTIVES:

Determine the toxicity of radiotherapy plus paclitaxel and cisplatin used as radiosensitization in patients with stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the cervix.
Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus radiotherapy in these patients.
Determine the effects of this regimen at the maximum tolerated dose on progression-free survival and overall survival in these patients.
Determine the site of local or distant recurrence in these patients after treatment with this regimen.

OUTLINE: This is a dose escalation study of paclitaxel.

Patients undergo external beam radiotherapy (RT) to the pelvic region 5 days a week during weeks 1-5. Patients receive paclitaxel IV over 1 hour immediately followed by cisplatin concurrently with pelvic field radiotherapy on days 1, 8, 15, 22, 29, and 36. Patients undergo low-dose rate (LDR) OR high-dose rate (HDR) brachytherapy. For patients undergoing LDR brachytherapy, intracavitary implants are inserted 1 or 2 times within 3 weeks after completion of external beam RT. For patients undergoing HDR brachytherapy, intracavitary implants are inserted once a week for 5 weeks beginning during week 4 of external beam RT. Patients may receive a parametrial boost.

Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or at time of recurrence until death.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-7 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Primary Purpose:

Treatment

Official Title:

A Phase I/II Study Of Whole Pelvic Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis

Study Start Date :

Nov 1, 1999

Actual Primary Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically proven stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the uterine cervix
Any cell type
No metastases to para-aortic lymph nodes, scalene nodes, or to other organs outside the radiation field at time of original staging
Study entry required within 8 weeks of diagnosis

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

GOG 0-2

Life expectancy:

More than 6 months

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal

Renal:

Creatinine less than 2.0 mg/dL
No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiation fields

Other:

Not pregnant
No septicemia or severe infection
No other invasive malignancy within the past 3 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior biologic therapy

Chemotherapy:

No prior chemotherapy for this or any prior malignancy

Endocrine therapy:

No prior endocrine therapy

Radiotherapy:

No prior pelvic or abdominal radiotherapy for this malignancy
No prior radiotherapy for any other prior malignancy
No more than 1 month interval between surgery and radiotherapy

Surgery:

See Radiotherapy

Other:

No other prior therapy for this malignancy
Stent or nephrostomy tube required if ureteral obstruction present

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
2	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
3	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612
4	CCOP - Central Illinois	Decatur	Illinois	United States	62794-9640
5	CCOP - Evanston	Evanston	Illinois	United States	60201
6	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
7	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
8	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
9	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
10	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
11	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
12	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
13	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
14	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
15	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
16	CCOP - Kansas City	Kansas City	Missouri	United States	64131
17	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
18	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
19	Cooper University Hospital	Camden	New Jersey	United States	08103-1489
20	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
21	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1065
22	Ireland Cancer Center	Cleveland	Ohio	United States	44106
23	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44124
24	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
25	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
26	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
27	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania	United States	15213-3180
28	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee	United States	37917
29	Gynecologic Oncology Network	Nashville	Tennessee	United States	37203
30	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee	United States	37232-2516
31	CCOP - Scott and White Hospital	Temple	Texas	United States	76508