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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165867
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 9, 2006
Information provided by:
Eisai Inc.

Brief Summary:
The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: E7070 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The objective response rate as defined by RECIST criteria.

Secondary Outcome Measures :
  1. Duration of response
  2. time to progression
  3. overall survival
  4. safety and tolerability of the combination

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165867

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Hôpitaux Civils de Colmar
Colmar, France, F- 68024
CRLC Val d'Aurelle
Montpellier, France, F-34298
Centre Antoine Lacassagne
Nice, France, F-06189
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Beatson Oncology Centre
Glasgow, United Kingdom, G11 6NT
Cookridge Hospital
Leeds, United Kingdom, LS16 6QB
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
Eisai Limited
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Study Director: Jantien Wanders Eisai Limited
Layout table for additonal information Identifier: NCT00165867    
Other Study ID Numbers: E7070-E044-214
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 9, 2006
Last Verified: October 2006
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action