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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rates

Principal Investigator

David Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

2147

NCT ID:

NCT00220116

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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