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A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00437268
First received: February 16, 2007
Last updated: April 16, 2010
Last verified: April 2010

February 16, 2007
April 16, 2010
March 2007
May 2009   (final data collection date for primary outcome measure)
Progression-free survival (PFS) rate [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
The primary endpoint for this study is progression-free survival (PFS) rate at 6 months.
Complete list of historical versions of study NCT00437268 on ClinicalTrials.gov Archive Site
  • Tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Safety and adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
The secondary efficacy endpoints for this study is progression free survival time.
Not Provided
Not Provided
 
A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Patients With Colorectal Cancer
A Randomized Phase 2 Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Patients With Recurrent Colorectal Cancer

To see how well enzastaurin in combination with irinotecan and cetuximab works versus irinotecan and cetuximab in patients who have progressed within 3 months.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumor
  • Drug: enzastaurin
    1125 mg loading dose then 500 mg, oral daily, 21 day cycles until progressive disease
    Other Name: LY317615
  • Drug: irinotecan
    300 mg/m2, IV, day 1 every 21 days until progressive disease
  • Drug: cetuximab
    400 mg/m2, IV, day 1, 250 mg/m2 day 8, day 15 cycle 1 then 250 mg/m2, IV, day 1, 8 and 15 of each cycle, IV, 21 day cycles until progressive disease
  • Experimental: A
    Interventions:
    • Drug: enzastaurin
    • Drug: irinotecan
    • Drug: cetuximab
  • Active Comparator: B
    Interventions:
    • Drug: irinotecan
    • Drug: cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients are eligible to be included in the study only if they meet all of the following criteria:

  1. Histologic diagnosis of colorectal cancer.
  2. Performance status of 0, 1, or 2 on the ECOG performance status schedule.
  3. Have had documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000) within 3 months after receiving FOLFOX plus bevacizumab as first-line therapy for locally advanced or metastatic disease, or within 6 months after receiving FOLFOX with or without bevacizumab in the adjuvant setting.
  4. Standard radiation therapy for rectal cancer is allowed. Patients must have recovered from the toxic effects (except for alopecia) of the treatment prior to study enrollment. Prior radiotherapy must be completed 4 weeks before study entry. Lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
  5. At least one uni-dimensionally measurable lesion meeting RECIST guidelines (at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques). Positron emission tomography [PET] scans and ultrasounds may not be used.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

  1. Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.
  2. Have previously completed or withdrawn from this study or any other study investigating enzastaurin, irinotecan, or cetuximab.
  3. Have a serious concomitant systemic disorder (eg, active infection including HIV, or cardiac disease) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
  4. Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
  5. Have a prior malignancy (other than colorectal cancer, or adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00437268
10538, H6Q-MC-S018
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours,EST) Eli Lilly and Company
Eli Lilly and Company
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP