CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With Oxaliplatin

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00969033
First received: August 28, 2009
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Drug: CS-1008
Drug: irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the difference in overall survival for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determine the difference in median survival for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determine the difference in objective response rate (ORR) for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine the Incidence of anti- CS-1008 antibody formation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-1008 with irinotecan
CS-1008 and irinotecan
Drug: CS-1008
CS-1008
Drug: irinotecan
irinotecan
Other Name: Camptosar
Active Comparator: irintoecan
irinotecan alone
Drug: irinotecan
irinotecan
Other Name: Camptosar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969033

Locations
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.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00969033     History of Changes
Other Study ID Numbers: CS1008-A-E203
Study First Received: August 28, 2009
Last Updated: January 30, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Irinotecan
Oxaliplatin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014