Working… Menu

CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With 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: NCT00969033
Recruitment Status : Terminated
First Posted : August 31, 2009
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
The purpose of this study is to determine the effect of CS-1008 in combination with irinotecan compared to irinotecan alone on Progression-Free Survival (PFS) in subjects with metastatic or advanced colorectal cancer (CRC) who have failed oxaliplatin-based first-line treatment.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: CS-1008 Drug: irinotecan Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Randomized, Controlled Trial of CS-1008 in Combination With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Oxaliplatin Based Regimen
Study Start Date : July 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CS-1008 with irinotecan
CS-1008 and irinotecan
Drug: CS-1008

Drug: irinotecan
Other Name: Camptosar

Active Comparator: irintoecan
irinotecan alone
Drug: irinotecan
Other Name: Camptosar

Primary Outcome Measures :
  1. Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Determine the difference in overall survival for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ]
  2. Determine the difference in median survival for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ]
  3. Determine the difference in objective response rate (ORR) for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ]
  4. To determine the Incidence of anti- CS-1008 antibody formation. [ Time Frame: 1 year ]

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.

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

Inclusion Criteria:

  • Histologically confirmed CRC which is now metastatic and after failure of oxaliplatin-based first-line treatment.
  • At least 18 years of age.
  • ECOG performance status =< 1.
  • Measurable disease based on RECIST criteria.
  • Adequate organ and bone marrow function as evidenced by:

    • Hemoglobin >= 9.0 g/dL (may be transfused to this level)
    • Absolute neutrophil count (ANC) >= 1.5 x 109/L
    • Platelet count >= 100 x 109/L
    • Serum creatinine =< upper limit of normal (ULN) or creatinine clearance > 50 mL/min
    • AST <= 2.5 x ULN in subjects with no liver metastasis and <= 5.0 x ULN in subjects with liver metastasis
    • Total bilirubin < 1.5 x ULN
  • Men and women of childbearing potential must be willing to consent to using effective contraception (e.g., hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for 3 months thereafter.
  • All female subjects of childbearing potential must have a negative pregnancy test (serum or urine) result within 7 days before initiating study treatment.
  • Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC/IRB approved ICF before performance of any study specific procedures or tests.
  • Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study.
  • Treatment with chemotherapy hormonal therapy, RT, minor surgery, or any investigational agent within 4 weeks before study enrollment. Treatment with nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery within six weeks prior to study enrollment. St John's Wort within 2 weeks prior to study enrollment or during the study.
  • History of any of the following conditions within 6 months before study enrollment:

    • Clinically significant myocardial infarction or severe/unstable angina pectoris
    • New York Heart Association (NYHA) class III or IV congestive heart failure (Section 17.2)
    • Clinically significant cerebrovascular accident, transient ischemic attack or pulmonary embolism- Clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease or asthma)
  • Presence of any of the following: Symptomatic brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis.
  • Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy.
  • History of malignancy other than CRC, unless there is the expectation that the malignancy has been cured, and tumor specific treatment for the malignancy has not been administered within the previous 5 years. Exceptions to this are non melanotic cancer of the skin and adequately treated carcinoma of the cervix-in-situ.
  • Previous treatment with CS 1008, other agonistic DR5 antibody agents, or TRAIL agents.
  • History of active chronic inflammatory bowel disease and/or bowel obstruction within the last 3 months.
  • Pregnant or breast feeding.
  • Known history of hypersensitivity reactions to irinotecan or to one of the excipients.

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): NCT00969033

Layout table for location information
United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom, CM1 7ET
Mount Vernon Hospital
Northwood, Middlesex, United Kingdom, HA6 2RN
Nottingham City Hospital
Nottingham, Notts, United Kingdom, NG5 1PB
Chrichill Hospital
Oxford, Oxon, United Kingdom, OX37LJ
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Clatterbridge Hospital
Bebington, Wirral, United Kingdom, CH634JY
Royal United Hospital Bath
Bath, United Kingdom, BA1 3NG
Russels Hall Hospital
Dudley, United Kingdom, DY1 2HQ
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
Daiichi Sankyo, Inc.

Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00969033     History of Changes
Other Study ID Numbers: CS1008-A-E203
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action