Trial Information

Summary: A Study of Xeloda (Capecitabine) Plus Radiotherapy in Patients With Locally Advanced Cervical Cancer

Status: No longer recruiting

Protocol Number: ML18418

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of Xeloda plus radiotherapy on overall tumor response rate in treatment-naïve patients with locally advanced squamous cell cancer of the cervix

Brief Summary: This study will evaluate the efficacy and safety of oral Xeloda plus radiotherapy as a first-line treatment in patients with advanced squamous cell cervical cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 59.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Cervical Cancer

Intervention Type: Drug

Intervention Name: capecitabine[Xeloda]

Primary Outcome: 1. Overall objective tumor response rate (compete response (CR) plus partial response (PR))

Key Secondary Outcomes: 1. Efficacy: 6 months of stable disease, time to progression, overall survival, duration of response. Safety: Adverse events (graded according to NCI CTCAE and RTOG), laboratory parameters, and ECOG PS

Inclusion Criteria:

  • female patients 18-75 years of age;
  • stage IIb-IIIb squamous cell cervical cancer;
  • >=1 measurable lesion.

Exclusion Criteria:

  • previous chemotherapy or radiotherapy;
  • total hysterectomy;
  • clinically significant cardiac disease;
  • history of lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome;
  • history of other malignancies, except cured basal cell cancer of the skin.

Gender: Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2005

Trial Registration Date: 10/27/2005

Date Last Updated: 10/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Manila, Philippines, 1000
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: November 17, 2008 at 2:34:38 PM


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