A Randomized Phase 2 Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Patients With Recurrent Colorectal Cancer

Eli Lilly and Company1 site in 1 country26 target enrollmentMarch 2007

ConditionsColorectal Cancer Colorectal Carcinoma Colorectal Tumor

Interventionsenzastaurin irinotecan cetuximab

Drugsenzastaurin irinotecan cetuximab

Overview

Phase: Phase 2
Intervention: enzastaurin
Conditions: Colorectal Cancer
Sponsor: Eli Lilly and Company
Enrollment: 26
Locations: 1
Primary Endpoint: Percentage of Participants With Progression-Free Survival (PFS) at 6 Months (PFS Rate)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

May 2009

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if they meet all of the following criteria:
•Histologic diagnosis of colorectal cancer.
•Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule.
•Have had documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0; Therasse et al. 2000) within 3 months after receiving 5-fluorouracil, leucovorin, and oxaliplatin (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.
•Standard radiation therapy for rectal cancer is allowed. Participants 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.
•At least one uni-dimensionally measurable lesion meeting RECIST v1.0 guidelines (at least 10 millimeters \[mm\] 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

•Participants will be excluded from the study if they meet any of the following criteria:
•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.
•Have previously completed or withdrawn from this study or any other study investigating enzastaurin, irinotecan, or cetuximab.
•Have a serious concomitant systemic disorder \[such as active infection including human immunodeficiency virus (HIV), or cardiac disease\] that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
•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.
•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. Participants 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.

Arms & Interventions

enzastaurin + irinotecan + cetuximab

Intervention: enzastaurin

enzastaurin + irinotecan + cetuximab

Intervention: irinotecan

enzastaurin + irinotecan + cetuximab

Intervention: cetuximab

irinotecan + cetuximab

Intervention: irinotecan

irinotecan + cetuximab

Intervention: cetuximab

Outcomes

Primary Outcomes

Percentage of Participants With Progression-Free Survival (PFS) at 6 Months (PFS Rate)

Time Frame: At 6 months from randomization

PFS was defined as the time from the date of study enrollment to the first date of progressive disease or death from any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. The PFS probability values were multiplied by 100 to obtain the percentage values.

Secondary Outcomes

Overall Survival (OS)(Randomization to date of death from any cause up to 21.9 months)
Percentage of Participants With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate)(Baseline to disease progression (up to 13.2 months))
Number of Participants With Adverse Events (AEs) or Who Died(Baseline to study completion (Cycle 31.5 [21 days/cycle] and 30-day safety follow-up))
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate)(Baseline to measured progressive disease up to 13.2 months)
Duration of Response(Time of response to progressive disease up to 13.2 months)