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

Royal Marsden NHS Foundation Trust

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Capecitabine, Oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00220116

2147

Details and patient eligibility

About

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

Enrollment

172 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.