NCT00003945

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

May 27, 2013

Status Verified

September 1, 2004

Enrollment Period

7.6 years

First QC Date

November 1, 1999

Last Update Submit

May 24, 2013

Conditions

Cervical Cancer

Keywords

recurrent cervical cancerstage IVB cervical cancercervical squamous cell carcinomacervical adenocarcinomacervical adenosquamous cell carcinoma

Interventions

cisplatinDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Cancer Center at Mercy Medical Center-Des Moines

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

Midlands Cancer Center at Midlands Community Hospital

Papillion, Nebraska, 68128-4157, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Instituto de Enfermedades Neoplasicas

Lima, 34, Peru

Location

San Juan City Hospital

San Juan, 00936-7344, Puerto Rico

Location

Related Publications (11)

  • Chase DM, Huang HQ, Wenzel L, Cella D, McQuellon R, Long HJ, Moore DH, Monk BJ. Quality of life and survival in advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 May;125(2):315-9. doi: 10.1016/j.ygyno.2012.01.047. Epub 2012 Feb 1.

    PMID: 22307062BACKGROUND

  • Moore DH, Tian C, Monk BJ, Long HJ, Omura GA, Bloss JD. Prognostic factors for response to cisplatin-based chemotherapy in advanced cervical carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2010 Jan;116(1):44-9. doi: 10.1016/j.ygyno.2009.09.006. Epub 2009 Oct 22.

    PMID: 19853287BACKGROUND

  • Paton F, Paulden M, Saramago P, Manca A, Misso K, Palmer S, Eastwood A. Topotecan for the treatment of recurrent and stage IVB carcinoma of the cervix. Health Technol Assess. 2010 May;14 Suppl 1:55-62. doi: 10.3310/hta14Suppl1/08.

    PMID: 20507804BACKGROUND

  • 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 Nov;199(5):539.e1-6. doi: 10.1016/j.ajog.2008.04.038. Epub 2008 Jun 20.

    PMID: 18565487BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1007/s11912-005-0007-z.

    PMID: 16221379BACKGROUND

  • 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. doi: 10.1016/j.ygyno.2005.09.023. Epub 2005 Oct 10.

    PMID: 16216315RESULT

  • 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. doi: 10.1200/JCO.2005.10.021. Epub 2005 May 23.

    PMID: 15911865RESULT

  • 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. doi: 10.1200/JCO.2005.10.522. Epub 2005 May 23.

    PMID: 15911864RESULT

  • 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.

    RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CisplatinTopotecan

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Harry J. Long, MD

    Mayo Clinic

    STUDY CHAIR

  • Higinia R. Cardenes, MD, PhD

    Indiana University Melvin and Bren Simon Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

June 1, 1999

Primary Completion

January 1, 2007

Last Updated

May 27, 2013

Record last verified: 2004-09

Locations

US(8)AU(1)PR(1)PE(1)