Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)

OHSU Knight Cancer Institute

Status and phase: Terminated; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Oxaliplatin; Drug: Erlotinib; Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00642746

3753

Details and patient eligibility

About

The purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be studying the side effects (good and bad) of alternating chemotherapy with erlotinib on metastatic colorectal cancer.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients must fulfill all of the following criteria to be eligible for study entry:

• Age 18-80
• Able to provide informed consent
• Biopsy proven unresectable metastatic adenocarcinoma of the colon or rectum
• Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer
• Radiographically measurable disease with at least one bidimensionally measurable lesion of > 1 cm
• Prior first-line regimen must have been completed at least 4 weeks prior to study treatment
• Use of biologic agents with first-line chemotherapy permitted
• Previous adjuvant regimens must have been greater than 6 months before inclusion
• Adequate organ function including bone marrow, liver and renal function as defined by the following values: absolute neutrophil count > 1500/microliter; Hgb > 9 g/dL; platelets > 90,000/microliter; International Normalized Ratio < 1.8 (unless in therapeutic range if taking warfarin or other warfarin-derivative anticoagulants and are being monitored regularly for changes in prothrombin time or International Normalized Ratio); bilirubin < 2 times the Upper Limit of Normal; alkaline phosphatase < 3 times the Upper Limit of Normal; aspartate aminotransferase/alanine aminotransferase < 5 times the Upper Limit of Normal; serum creatinine < 1.5 times the Upper Limit of Normal
• Eastern Cooperative Oncology Group status < 2

Exclusion criteria

Patients meeting any of the following criteria are ineligible for study entry:

• Prior second-line chemotherapy regimens for colorectal cancer
• Prior treatment with erlotinib or gefitinib
• Central Nervous System metastasis
• Second malignancies less than 5 years prior to enrollment. Completely resected basal or squamous cell carcinoma of the skin is allowed.
• Untreated/unresolved bowel obstruction
• Inability to take oral mediations
• HIV positive
• Pregnancy
• Other uncontrolled medical illnesses
• Current diarrhea > grade 2
• Symptomatic angina or uncontrolled congestive heart failure

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

FOLFOX with Erlotinib

Experimental group

Description:

Subjects received FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFOX on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.

Treatment:

Drug: Fluorouracil

Drug: Leucovorin

Drug: Erlotinib

Drug: Oxaliplatin

FOLFIRI with Erlotinib

Experimental group

Description:

Subjects received FOLFIRI (Leucovorin, Fluorouracil, and Irinotecan) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFIRI on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.

Treatment:

Drug: Fluorouracil

Drug: Irinotecan

Drug: Leucovorin

Drug: Erlotinib