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

Sponsors and Collaborators:	Gynecologic Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003945

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 III

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

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)

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.)

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

National Cancer Institute (NCI)

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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Long HJ 3rd, Monk BJ, Huang HQ, Grendys EC Jr, McMeekin DS, Sorosky J, Miller DS, Eaton LA, Fiorica JV; Gynecologic Oncology Group. Clinical results and quality of life analysis for the MVAC combination (methotrexate, vinblastine, doxorubicin, and cisplatin) in carcinoma of the uterine cervix: A Gynecologic Oncology Group study. Gynecol Oncol. 2006 Mar;100(3):537-43. Epub 2005 Oct 10.

Long HJ 3rd, Bundy BN, Grendys EC Jr, Benda JA, McMeekin DS, Sorosky J, Miller DS, Eaton LA, Fiorica JV; Gynecologic Oncology Group Study. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2005 Jul 20;23(21):4626-33. Epub 2005 May 23.

Monk BJ, Huang HQ, Cella D, Long HJ 3rd; Gynecologic Oncology Group Study. Quality of life outcomes from a randomized phase III trial of cisplatin with or without topotecan in advanced carcinoma of the cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2005 Jul 20;23(21):4617-25. Epub 2005 May 23. Erratum in: J Clin Oncol. 2005 Nov 20;23(33):8549.

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.

Other Publications:

Plaxe SC, Brooks SE, Tian C, Bloss JD, Moore DH, Long HJ. Influence of race on tolerance of platinum-based chemotherapy and clinical outcomes in women with advanced and recurrent cervical cancer: a pooled analysis of 3 Gynecologic Oncology Group studies. Am J Obstet Gynecol. 2008 Jun 18; [Epub ahead of print]

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.

Tewari KS, Monk BJ. Gynecologic oncology group trials of chemotherapy for metastatic and recurrent cervical cancer. Curr Oncol Rep. 2005 Nov;7(6):419-34. Review.

Study ID Numbers:	CDR0000067138, GOG-0179, ECOG-G0179
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003945
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

Study placed in the following topic categories:

Epidermoid carcinoma
Cisplatin
Squamous cell carcinoma
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Topotecan

Adenocarcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009