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

NCT00220116 | Completed Phase 2

• 1 other identifier: 2147
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rates

Secondary Outcomes (6)

• Treatment related toxicity

• Progression free survival (If not resected)

• Disease free Survival (From metastastectomy, if resected)

• Overall Survival

• 60 Day all cause mortality

Interventions

Capecitabine, Oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• David Cunningham

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2002
• Last Updated: January 6, 2010

Record last verified: 2010-01

Locations

GB (1)