Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix

NCT00030472 | Terminated Phase 2

• 2 other identifiers: CDR0000069168GOG-0127R
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 17

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.

Conditions

Cervical Cancer

Keywords

recurrent cervical cancer; stage IVB cervical cancer; cervical squamous cell carcinoma

Interventions

pegylated liposomal doxorubicin hydrochloride DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma (SCC) of the cervix * Persistent or recurrent progressive disease * Must have failed local therapeutic measures and considered incurable * 1 prior chemotherapeutic regimen for SCC of the cervix required * Initial treatment may include high-dose therapy, consolidation, or extended therapy * Ineligible for a higher priority GOG protocol * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Target lesion may not be within a previously irradiated field PATIENT CHARACTERISTICS: Age: * Any age Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm3 * Absolute neutrophil count at least 1,500/mm3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No congestive heart failure * No unstable angina * No myocardial infarction or new cardiac arrhythmia in the past 6 months Other: * No active infection requiring antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * 1 prior noncytotoxic biologic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic cytostatic regimen for recurrent or persistent disease management) * At least 3 weeks since prior biologic or immunologic therapy for SCC of the cervix Chemotherapy: * See Disease Characteristics * No prior doxorubicin or doxorubicin HCl liposome * 1 prior noncytotoxic cytostatic regimen allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic biologic regimen for recurrent or persistent disease management) * No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens * Recovered from prior chemotherapy Endocrine therapy: * At least 1 week since prior hormonal therapy for SCC of the cervix * Concurrent hormone replacement therapy allowed Radiotherapy: * See Disease Characteristics * Recovered from prior radiotherapy Surgery: * Recovered from prior surgery Other: * At least 3 weeks since other prior therapy for SCC of the cervix * No prior anticancer treatment that precludes study

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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (17)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1740, United States

Location

Community Hospital of Los Gatos

Los Gatos, California, 95032, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103-1489, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11794-8091, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0526, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

University of Texas M.D. Anderson CCOP Research Base

Houston, Texas, 77030-4009, United States

Location

Fletcher Allen Health Care - Medical Center Campus

Burlington, Vermont, 05401, United States

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (1)

• Rose PG, Blessing JA, Lele S, Abulafia O. Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Aug;102(2):210-3. doi: 10.1016/j.ygyno.2005.11.048. Epub 2006 Feb 14.

  PMID: 16478630 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Peter G. Rose, MD

  MetroHealth Cancer Care Center at MetroHealth Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: December 1, 2001
• Primary Completion: October 1, 2006
• Last Updated: April 11, 2013

Record last verified: 2004-09

Locations

US (16); NO (1)