Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

NCT00016926 | Completed Phase 2

• 2 other identifiers: CDR0000068633GOG-0076CC
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 10

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 of capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.

Conditions

Cervical Cancer

Keywords

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

Interventions

capecitabine DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix * Documented disease progression after local therapy and considered incurable * At least 1 target lesion measurable in at least 1 dimension * At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan * Target lesion cannot be in a previously irradiated field PATIENT CHARACTERISTICS: Age: * Any age 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 upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine clearance at least 50 mL/min Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No neuropathy (sensory and motor) greater than grade I PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: * At least 3 weeks since prior chemotherapy for the malignant tumor and recovered * No prior cytotoxic therapy (except when used as a radiosensitizer) * No prior chemotherapy for other malignancy Endocrine therapy: * At least 1 week since prior hormonal therapy for the malignant tumor * Concurrent hormone replacement therapy allowed Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy for the malignant tumor and recovered * No prior radiotherapy for other malignancy Surgery: * Recovered from prior surgery Other: * At least 3 weeks since any other prior therapy for the malignant tumor * No prior anticancer therapy that contraindicates study therapy * No concurrent amifostine or other protective reagents

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 (10)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Brookview Research, Inc.

Nashville, Tennessee, 37203, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (1)

• Garcia AA, Blessing JA, Darcy KM, Lenz HJ, Zhang W, Hannigan E, Moore DH. Phase II clinical trial of capecitabine in the treatment of advanced, persistent or recurrent squamous cell carcinoma of the cervix with translational research: a gynecologic oncology group study. Gynecol Oncol. 2007 Mar;104(3):572-9. doi: 10.1016/j.ygyno.2006.09.002. Epub 2006 Oct 17.

  PMID: 17049588 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Capecitabine

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Agustin Garcia, MD

  University of Southern California

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: July 1, 2007
• Last Updated: May 27, 2013

Record last verified: 2004-05

Locations

US (9); NO (1)