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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220116
• Other study ID #: 2147
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2005
• Last updated: January 5, 2010
• Start date: August 2002

Study information

• Verified date: January 2010
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Capecitabine, Oxaliplatin

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rates
Secondary	Treatment related toxicity
Secondary	Progression free survival (If not resected)
Secondary	Disease free Survival (From metastastectomy, if resected)
Secondary	Overall Survival
Secondary	60 Day all cause mortality
Secondary	Number undergoing liver resections/curative resection (Ro) rate