Colon Cancer Clinical Trial

Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer

Summary

This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles, once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen. The study is being done to evaluate whether the study drug is safe and tolerable at different dose levels with these dosing schedules and to obtain preliminary information on its efficacy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed colorectal adenocarcinoma.
Stage IV (metastatic) disease.
Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer.
Adequate performance status (Eastern Cooperative Oncology Group (ECOG) 0 or 1).
Expected survival > 6 months.
Carcinoembryonic antigen (CEA) plasma levels > 5 ng/mL.
Measurable disease by computed tomography (CT) or Magnetic resonance imaging (MRI).
At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
At least 2 weeks beyond corticosteroids.
Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
Otherwise, all toxicity at study entry ≤ Grade 1 by National cancer institute common terminology criteria for adverse events (NCI CTC) v4.0.

Exclusion Criteria:

Women who are pregnant or lactating.
Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
Individuals with Gilbert's disease or known central nervous system (CNS) metastatic disease.
Individuals with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension).
Individuals with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval.
Individuals known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
Known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Known history of clinically significant active chronic obstructive pulmonary disease (COPD), or other moderate-to-severe chronic respiratory illness present within 6 months.
Infection requiring intravenous antibiotic use within 1 week.
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

92

Study ID:

NCT01605318

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 7 Locations for this study

See Locations Near You

UCLA Jonsson Comprehensive Cancer Center
Santa Monica California, 90404, United States
University of Colorado Anschutz Medical Campus
Aurora Colorado, 80045, United States
Helen F. Graham Cancer Center-Christiana Care
Newark Delaware, 19713, United States
IUHealth Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43202, United States
Fox Chase
Philadelphia Pennsylvania, 19111, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37212, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

92

Study ID:

NCT01605318

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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