Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003945

Collaborator

National Cancer Institute (NCI) (NIH), Eastern Cooperative Oncology Group (Other)

400

Enrollment

Locations

36.4

Patients Per Site

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. It is not yet known which chemotherapy regimen is more effective for cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three different chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical cancer.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: cisplatin Drug: topotecan hydrochloride	Phase 3

Detailed Description

OBJECTIVES:

Compare the response rate and survival of patients with stage IVB, recurrent, or persistent carcinoma of the cervix treated with cisplatin only vs cisplatin plus topotecan vs methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). (Arm III (MVAC) closed to accrual effective 07/23/2001.)
Compare the toxic effects of these regimens in this patient population.
Compare health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to GOG performance status. Patients are randomized to one of three treatment arms. (Arm III closed to accrual effective 07/23/2001.)

Arm I: Patients receive cisplatin IV once every 21 days.
Arm II:Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin IV (beginning after topotecan infusion) on day 1. Courses repeat every 21 days.
Arm III:Patients receive methotrexate IV on days 1, 15, and 22, vinblastine IV on days 2, 15, and 22, and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28 days. (Arm III closed to accrual effective 07/23/2001.) Treatment in all arms continues for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. (Arm III closed to accrual effective 07/23/2001.)

Quality of life is assessed before randomization, before course 2, before course 5 (arms I and II), before course 4 (arm III), and at 9 months. (Arm III closed to accrual effective 07/23/2001.)

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients (133 per treatment arm) will be accrued for this study within 2 years. (Arm III closed to accrual effective 07/23/2001.)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix

Study Start Date :

Jun 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 confirmed stage IVB, recurrent, or persistent carcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiotherapy
Eligible subtypes:
Squamous cell carcinoma
Adenosquamous carcinoma
Adenocarcinoma
Measurable disease by physical examination, radiography, CT scan, or MRI
Measurable disease by CT scan/MRI without biopsy confirmation allowed if lesions are at least 3 cm and well defined
No craniospinal metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

GOG 0-2

Life expectancy:

Not specified

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
Alkaline phosphatase no greater than 3 times normal

Renal:

Creatinine no greater than 1.5 mg/dL
No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No clinically significant infection
No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
Body surface area no greater than 2.0 m^2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 6 weeks since prior chemoradiotherapy and recovered
No prior chemotherapy except when used concurrently with radiotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
See Chemotherapy
At least 3 weeks since prior radiotherapy only and recovered

Surgery:

Recovered from prior surgery

Other:

No prior anticancer treatment that would preclude study therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
2	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
3	Mercy Cancer Center at Mercy Medical Center-Des Moines	Des Moines	Iowa	United States	50314
4	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
5	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska	United States	68128-4157
6	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
7	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
8	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54307-3453
9	Westmead Hospital	Westmead	New South Wales	Australia	2145
10	Instituto de Enfermedades Neoplasicas	Lima		Peru	34
11	San Juan City Hospital	San Juan		Puerto Rico	00936-7344