Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

NCT00049101 | Completed Phase 1

• 3 other identifiers: CDR0000257808MSKCC-02039NCI-5371
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining erlotinib with combination chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib with oxaliplatin, leucovorin, and fluorouracil in treating patients who have metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Interventions

erlotinib hydrochloride DRUG

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed colon or rectal cancer * Metastatic or unresectable disease * Unidimensionally measurable disease required for phase II only * At least 20 mm by x-ray, CT scan, MRI, or photography * The following are not considered measurable: * Pleural effusion or ascites * Osteoblastic lesions * Evidence of disease on bone scan alone * Progressive irradiated lesions alone * Bone marrow involvement * Brain metastases * Malignant hepatomegaly by physical exam alone * Chemical markers (e.g., carcinoembryonic antigen) * Recurrent disease after surgery or radiotherapy is considered measurable as long as the following criteria are met: * At least 4 weeks since prior surgery or radiotherapy * Measurable disease exists outside the radiation port or clear progression exists within the radiation port * Tissue accessible for immunohistochemical evidence of epidermal growth factor receptor expression from a metastatic site (phase II only) * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No unstable angina pectoris * No symptomatic congestive heart failure * No cardiac arrhythmia * No uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg) Opthalmic * No abnormalities of the cornea (e.g., severe dry eye syndrome or Sjogren's syndrome) * No congenital abnormality (e.g., Fuch's dystrophy) * No abnormal slit-lamp examination using vital dye (e.g., fluorescein or Bengal-Rose) * No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear-production test) * Mild dry eye syndrome allowed if patient can use artificial tears and ophthalmologist concurs Gastrointestinal * No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation * No active peptic ulcer disease Other * Must be able and willing to undergo a mediport insertion * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except previously excised and inactive basal cell or squamous cell skin cancer * No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib or other study drugs (e.g., epidermal growth factor inhibitors like cetuximab) * No significant traumatic injury within the past 3 weeks * No peripheral neuropathy grade 2 or greater * No ongoing or active infection * No other uncontrolled concurrent illness that would preclude study entry * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Phase I: * Prior chemotherapy allowed * Phase II: * No prior chemotherapy for metastatic disease * Prior adjuvant therapy allowed if disease progresses during adjuvant therapy * No prior oxaliplatin Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics * More than 3 weeks since prior major surgery and recovered * No prior surgical procedures affecting absorption Other * No other concurrent investigational agents * No other concurrent anticancer agents or therapies (commercial or investigational) * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Erlotinib Hydrochloride; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

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

Study Officials

• Leonard B. Saltz, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2002
• Study Completion: August 1, 2004
• Last Updated: June 24, 2013

Record last verified: 2004-04

Locations

US (1)