An Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00165867
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Eisai Limited
• Public title: An Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin
• Date of first enrolment: April 2005
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00165867
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, United Kingdom

Contacts

• Name: Jantien Wanders
• Affiliation: Eisai Limited

Key inclusion & exclusion 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
metastases

- 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
neoplasia

- 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
protection

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

Drug: E7070

Primary Outcome(s)

The objective response rate as defined by RECIST criteria.

Secondary Outcome(s)

overall survival

safety and tolerability of the combination

time to progression

Duration of response

Secondary ID(s)

E7070-E044-214

Source(s) of Monetary Support

Please refer to primary and secondary sponsors