Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00838578
• Other study ID #: KRN330-US-02
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 2009
• Est. completion date: October 2012

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.

Description:

Phase II portion is an open-label, single arm study. Based on the results of the Phase I portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the Phase II portion. To be eligible for the Phase II portion, a patient will have recurred or progressed within 6 months of the last cycle of FOLFOX/CapOx +/- bevacizumab (first-line or adjuvant regimen for metastatic colorectal cancer). Patients will continue the treatment until disease progression.

Per protocol, the decision was made to terminate the study based on interim analysis results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when 0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have histologically confirmed colorectal cancer that is metastatic with measurable disease.

• For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.

• At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).

• Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.

• At least 4 weeks have elapsed since any major surgery.

• Have ECOG performance status of 0, 1, or 2.

• Have adequate bone marrow and organ function

Exclusion Criteria:

• Have an active, uncontrolled infection.

• Have known HIV positive status.

• Have known or suspected cerebral metastasis.

• Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).

• Have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).

• Have a history of greater than or equal to Grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).

• Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• KRN330
KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.

Drug:
• Irinotecan
Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.

Locations

Country	Name	City	State
United States	Emory University - Winship Cancer Institute	Atlanta	Georgia
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	University of Florida COllege of Medicine/Shands Cancer Center	Gainesville	Florida
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Miami - Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	NYU Clinical Trials Office, New York University Cancer Institute	New York	New York
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Lombardi Comprehensive Cancer Center, Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0		Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months