Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
This study has been completed.
Sponsor:
Gynecologic Oncology Group
Collaborators:
Eastern Cooperative Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003945
First received: November 1, 1999
Last updated: February 22, 2012
Last verified: September 2004
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Drug: topotecan hydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 400 |
| Study Start Date: | June 1999 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
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.)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003945
Locations
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Iowa | |
| Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center-Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Nebraska | |
| Midlands Cancer Center at Midlands Community Hospital | |
| Papillion, Nebraska, United States, 68128-4157 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Pennsylvania | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Wisconsin | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54307-3453 | |
| Australia, New South Wales | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Peru | |
| Instituto de Enfermedades Neoplasicas | |
| Lima, Peru, 34 | |
| Puerto Rico | |
| San Juan City Hospital | |
| San Juan, Puerto Rico, 00936-7344 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Eastern Cooperative Oncology Group
Investigators
| Study Chair: | Harry J. Long, MD | Mayo Clinic |
| Study Chair: | Higinia R. Cardenes, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
Additional Information:
Publications:
Grendys EC Jr, Long HJ, Bundy BN, et al.: Randomized phase III trial of cisplatin vs cisplatin plus topotecan vs the combination of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) in stage IVB, recurrent or persistent carcinoma of the uterine cervix: a Gynecologic Oncology Group study. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-039, 12, 2004.
Monk BJ, Huang H, Cella D, et al.: Quality of life outcomes from GOG 179: a phase III trial of cisplatin vs cisplatin/topotecan in recurrent or persistent carcinoma of the cervix. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-142, 42, 2004.
Moore DH, Tian C, Monk BJ, et al.: Factors predictive of response to cisplatin-based chemotherapy in stage IVB persistent or recurrent cervical carcinoma: a multivariate analysis of three Gynecologic Oncology Group trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-5534, 282s, 2007.
| ClinicalTrials.gov Identifier: | NCT00003945 History of Changes |
| Other Study ID Numbers: | CDR0000067138, GOG-0179, ECOG-G0179 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 22, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent cervical cancer stage IVB cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Uterine Cervical Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Cisplatin Topotecan Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013