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Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Inclusion Criteria

Inclusion criteria:

- Ambulant male or female patients with metastatic colorectal cancer who have been
previously treated with 5-fluorouracil/leucovorin and oxaliplatin. Patients must
fulfill the following criteria to be included in the study:

- At least 4 doses of previous treatment with oxaliplatin

- All previous treatment (including surgery and radiotherapy) must have been completed
at least four weeks prior to study entry and any acute toxicities must have resolved

- At least one uni-dimensionally measurable lesion according to RECIST criteria (the
following do not qualify as measurable lesions: bone, leptomeningeal disease,
ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses
that are not confirmed and followed by imaging techniques, and cystic lesions)

- Aged greater than or equal to 18 years

- Histologically or cytologically confirmed colorectal cancer

- Karnofsky performance status greater than or equal to 70%

- Written informed consent to participate in the study

Exclusion criteria:

Patients with the following characteristics will not be included in the study:

- More than three previous lines of chemotherapy (including neo-adjuvant and adjuvant)

- Prior treatment with cytotoxics other than 5- fluorouracil/leucovorin (capecitabine
and UFT are permitted) and oxaliplatin. Prior epidermal growth factor receptor
targeted and anti-angiogenic therapy is permitted.

- Untreated brain metastases (patients who have been treated for CNS metastases must be
asymptomatic and radiologically stable for 4 weeks prior to entry). Patients must not
have clinical symptoms from brain metastases and must not be taking corticosteroids
for the treatment of brain metastases. Patients must not have leptomeningeal

- Any of the following laboratory parameters:

1. hemoglobin <10 g/dl;

2. neutrophils <1.5 x 109/L;

3. platelets <100 x 109/L;

4. serum bilirubin >25 mmol/l (1.5 mg/dl);

5. other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit
in the presence of hepatic metastases);

6. serum creatinine >1.5 x ULN;

7. serum calcium (corrected for albumin) >=11.5 mg/dl. 5. History of Gilbert’s
Disease or conjugated hyperbilirubinemia 6. Concurrent or previous malignancy of
a different tumor type within five years of starting the study except for
adequately treated non- melanoma skin cancer or cervical intraepithelial

- Uncontrolled infections

- Clinically significant cardiac impairment or unstable ischemic heart disease
including a myocardial infarction within six months of study start

- Chronic inflammatory bowel disease and/or bowel obstruction

- History of hypersensitivity to sulfonamides

- History of severe hypersensitivity reactions to one of the excipients of irinotecan

- Treatment within two weeks before the start of the stud y with any of the following:
coumarin anti-coagulants, terfenadine, cisapride, cyclosporin, tacrolimus,
theophylline, diazepam, sulphonylurea hypoglycaemics, phenytoin, or carbamazepine

- Any treatment with investigational drugs within 30 days before the start of the study

- Pregnancy or lactation (all women of childbearing potential must have a negative
pregnancy test before inclusion in the study; post-menopausal women must be
amenorrheic for at least 12 months). Female patients must use adequate contraceptive

- Fertile males not willing to use contraception or whose female partners are not using
adequate contraceptive protection

- History of alcoholism, drug addiction, or any psychiatric or psychological condition
which, in the opinion of the investigator, would impair study compliance.

- Legal incapacity

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The objective response rate as defined by RECIST criteria.

Principal Investigator

Jantien Wanders

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Limited


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms