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

NCT00642746 | Terminated Phase 2 Results DMC

• 1 other identifier: 3753
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Colon; Cancer; Metastatic; Colorectal

Outcome Measures

Primary Outcomes (1)

• Response Rates of Radiographically Measurable Disease

  The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

  Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.

Secondary Outcomes (2)

• Second-line Progression Free Survival

  Upon completion of follow-up, for an average of 99 days following the initiation of study treatment.

• Time to Second Progression (From Start of First-Line Regimen)

  Documented by Follow-up CT scans following first line treatment, average of 225 days.

Study Arms (2)

FOLFOX with Erlotinib

EXPERIMENTAL

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.

Drug: Erlotinib; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

FOLFIRI with Erlotinib

EXPERIMENTAL

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.

Drug: Erlotinib; Drug: Fluorouracil; Drug: Leucovorin; Drug: Irinotecan

Interventions

Erlotinib 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.

Also known as: Tarceva

FOLFIRI with Erlotinib; FOLFOX with Erlotinib

Fluorouracil 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.

FOLFIRI with Erlotinib; FOLFOX with Erlotinib

Leucovorin DRUG

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

FOLFIRI with Erlotinib; FOLFOX with Erlotinib

Oxaliplatin DRUG

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

FOLFOX with Erlotinib

Irinotecan DRUG

Chemotherapy agent given intravenously at 180 mg/m2.

FOLFIRI with Erlotinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Genentech, Inc.: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Erlotinib Hydrochloride; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Limitations and Caveats

Study terminated before target enrollment was reached due to excessive toxicities and limited enrollment.

Results Point of Contact

• Title: Charles Lopez, MD
• Organization: OHSU Knight Cancer Institute

lopezc@ohsu.edu

503-494-8534

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 25, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 26, 2014
• Results First Posted: September 26, 2014

Record last verified: 2014-09

Locations

US (1)