Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

NCT00039442 | Completed Phase 2

• 4 other identifiers: GOG-0128GNCI-2012-02469CDR0000069384U10CA027469
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Recurrent Cervical Carcinoma

Outcome Measures

Primary Outcomes (4)

• Duration of objective response

  Up to 7 years

• Frequency of adverse events, graded according to CTC version 2.0

  Up to 7 years

• Frequency of objective response

  Up to 7 years

• Severity of observed adverse events, graded according CTC version 2.0

  Up to 7 years

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Capecitabine; Other: Laboratory Biomarker Analysis

Interventions

Capecitabine DRUG

Given orally

Treatment

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix
• Persistent or recurrent disease
• Eligible subtypes include:
• Adenocarcinoma
• Adenosquamous cell carcinoma
• Undifferentiated carcinoma
• Documented disease progression
• At least 1 unidimensionally measurable target lesion outside prior irradiation field
• At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, and MRI)
• At least 10 mm by spiral CT scan
• Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent non-SCC of the cervix
• Radiosensitizing chemotherapy administered in combination with primary radiotherapy is not counted as a systemic chemotherapy regimen
• Tissue blocks from initial diagnosis, metastasis, or recurrence available for submission to the GOG tissue bank
• Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), defined as any Temporarily closed GOG phase III protocol for the same patient population
• Performance status - GOG 0-2

Sponsors & Collaborators

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

Study Sites (1)

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, 85012, United States

Location

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

• Katherine Look

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: April 29, 2002
• Primary Completion: December 7, 2005
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

US (1)