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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Capecitabine, Oxaliplatin
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Marsden Hospital

Outcomes

Primary Outcome Measures

Objective response rates

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2005
Last Updated
January 5, 2010
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00220116
Brief Title
Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer
Official Title
A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Capecitabine, Oxaliplatin
Primary Outcome Measure Information:
Title
Objective response rates
Secondary Outcome Measure Information:
Title
Treatment related toxicity
Title
Progression free survival (If not resected)
Title
Disease free Survival (From metastastectomy, if resected)
Title
Overall Survival
Title
60 Day all cause mortality
Title
Number undergoing liver resections/curative resection (Ro) rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cunningham
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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