Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer

A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.

To assess the efficacy and safety of the combination of capecitabine and oxaliplatin in the 1st, 2nd or subsequent line treatment of metastatic colorectal cancer, and also in the neo-adjuvant and adjuvant setting of resectable metastases.

Primary Endpoint: Objective response rates

Secondary Endpoints: Treatment related toxicity Progression free survival (If not resected) Disease free Survival (From metastastectomy, if resected) Overall Survival 60 Day all cause mortality Number undergoing liver resections/curative resection (Ro) rate

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine, Oxaliplatin

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18
• Histologically proven colorectal adenocarcinoma, requiring therapy as defined by one of the four treatment subgroups
• No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
• Unidimensional measurable disease as assessed by CT. (Unless adjuvant therapy only)
• Adequate bone marrow function; Hb >10g/dl, platelets >100 x109/l, WBC >3x109/l, Neut >1.5x109/l.
• Adequate liver function: Serum Bilirubin <1.5 x upper limit of institutional normal
• Adequate renal function, calculated Creatinine Clearance >50mls/min
• No concurrent uncontrolled medical conditions
• WHO performance status 0,1 or 2
• Adequate contraceptive precautions, if appropriate
• Informed written consent
• Negative pregnancy test in women of child bearing age
• Life expectancy > 3 months

Exclusion Criteria:

• Medical or psychiatric condition that comprise the patient's ability to take informed consent.
• Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months.
• Patients with any significant symptoms or history of peripheral neuropathy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response rates

Secondary Outcome Measures

Outcome Measure
Overall Survival
Treatment related toxicity
Progression free survival (If not resected)
Disease free Survival (From metastastectomy, if resected)
60 Day all cause mortality
Number undergoing liver resections/curative resection (Ro) rate

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: David Cunningham, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: August 1, 2002

Study Registration Dates

• First Submitted: September 19, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 6, 2010
• Last Update Submitted That Met QC Criteria: January 5, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: 2147