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

NCT ID: NCT00642746

Last Updated: 2014-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFOX with Erlotinib

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.

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate.

Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage.

Fluorouracil

Intervention Type: DRUG

Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours.

Leucovorin

Intervention Type: DRUG

Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing.

Oxaliplatin

Intervention Type: DRUG

Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2.

FOLFIRI with Erlotinib

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.

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate.

Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage.

Fluorouracil

Intervention Type: DRUG

Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours.

Leucovorin

Intervention Type: DRUG

Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing.

Irinotecan

Intervention Type: DRUG

Chemotherapy agent given intravenously at 180 mg/m2.

Interventions

Erlotinib

Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate.

Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage.

Intervention Type: DRUG

Fluorouracil

Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours.

Intervention Type: DRUG

Leucovorin

Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing.

Intervention Type: DRUG

Oxaliplatin

Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2.

Intervention Type: DRUG

Irinotecan

Chemotherapy agent given intravenously at 180 mg/m2.

Intervention Type: DRUG

Other Intervention Names

Tarceva

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

OSI Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

3753

Identifier Type: -

Identifier Source: org_study_id