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Home > "E" Clinical Trials Conditions > Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Colorectal Cancer  Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Colorectal Cancer
Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Colorectal Cancer
For Condition: Colon Cancer,Rectal Cancer
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with combination chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with fluorouracil, leucovorin, and oxaliplatin in treating patients who have metastatic or locally advancedcolorectal cancer.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of erlotinib in combination with fluorouracil, leucovorin calcium, and oxaliplatin (FOLFOX-4) in patients with metastatic or locally advanced colorectal cancer. - Determine the toxicity profile of this regimen in these patients. - Determine the antitumor activity of this regimen in these patients. Secondary - Determine the pharmacokinetics of this regimen in these patients. - Correlate expression and activation of epidermal growth factor receptor and related signaling pathways with outcome of patients treated with this regimen. - Determine the biological effects of erlotinib in these patients and its relationship with dose and plasma concentration. - Determine whether fludeoxyglucose F 18 positron emission tomography scan can predict the biological effects in and outcome of patients treated with this regimen. OUTLINE: This is a dose-escalation study of erlotinib. Patients receive oral erlotinib once daily on days 1-28. Patients also receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 22 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 38 patients will be accrued for this study within 12-19 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed colorectal adenocarcinoma - Metastatic or locally advanced - Not amenable to curative therapy - Unidimensionally measurable disease - At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - The following are not considered measurable disease: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Available sample of tumor tissue for assessment of epidermal growth factor receptor - May be obtained at initial resection, biopsy or resection of a metastatic lesion, or biopsy specifically for this study - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks 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 no greater than 2 mg/dL - AST and ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastasis present) Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal - No gastrointestinal disease resulting in an inability to take oral medication - No requirement for intravenous alimentation - No active peptic ulcer disease Ophthalmic - No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal corneal sensitivity test (Schirmer test or similar tear production test) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Sufficient central venous access - No significant traumatic injury within the past 21 days - No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib, fluorouracil, leucovorin calcium, or oxaliplatin - No significant neuropathy greater than grade 2 - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 28 days since prior chemotherapy for metastatic disease - At least 120 days since prior adjuvant chemotherapy - No prior oxaliplatin Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - More than 21 days since prior major surgery - No prior surgical procedures affecting absorption Other - No prior epidermal growth factor receptor-targeting therapy - No concurrent phenytoin - No concurrent carbamazepine - No concurrent rifampin - No concurrent phenobarbital - No concurrent Hypericum perforatum (St. John's Wort) - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational or commercial agents or therapies intended to treat the malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ManuelHidalgo, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Manuel Hidalgo 410-502-7149
Additional Information:
Study ID Numbers: CDR0000301882; NCI-5869,JHOC-J0220,JHOC-02072506
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060411
Other Colon Cancer Studies:
1. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
2. Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
3. Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
4. Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer
5. Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer
Related Studies:
Other Colon Cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Colorectal Cancer
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