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

This study has been completed.
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220116
First received: September 19, 2005
Last updated: January 5, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Drug: Capecitabine, Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

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

Enrollment: 172
Study Start Date: August 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00220116

Locations
United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Jane Lawrence, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220116     History of Changes
Other Study ID Numbers: 2147
Study First Received: September 19, 2005
Last Updated: January 5, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014