Status:
COMPLETED
Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in d...
Detailed Description
OBJECTIVES: * Determine the toxicity of erlotinib, mFOLFOX6, and bevacizumab in patients with metastatic colorectal cancer. * Determine the efficacy of this regimen in these patients. * Determine the...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Biopsy-accessible metastatic disease
- Measurable disease
- No CNS metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- At least 3 months
- Hematopoietic
- WBC ≥ 4,000/mm\^3 OR
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- No bleeding disorder
- Hepatic
- Bilirubin ≤ 1.5 mg/dL
- Albumin ≥ 2.5 g/dL
- Renal
- Creatinine ≤ 1.5 mg/dL
- Urine protein:creatine ratio \< 1.0
- Cardiovascular
- Blood pressure ≤ 150/100 mmHg
- No arterial thrombotic event within the past 6 months
- No New York Heart Association grade II-IV congestive heart failure
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after completion of study treatment
- No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other malignancy with \< 10% chance of relapse within 3 years
- No uncontrolled infection
- No severe uncontrolled illness that would preclude study participation
- No peripheral neuropathy interfering with function
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious non-healing wound, ulcer, or bone fracture
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent immunotherapy
- No concurrent sargramostim (GM-CSF)
- Chemotherapy
- No prior chemotherapy, including oxaliplatin, for metastatic disease
- Prior adjuvant oxaliplatin allowed provided disease progressed \> 12 months after completion of oxaliplatin
- At least 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas)
- No more than 2 courses of prior mitomycin
- No concurrent chemotherapy
- Endocrine therapy
- No concurrent anticancer hormonal therapy
- Radiotherapy
- At least 2 weeks since prior radiotherapy
- No prior radiotherapy to \> 15% of bone marrow
- No concurrent radiotherapy
- Surgery
- At least 4 weeks since prior major surgery
- At least 1 week since prior minor surgery
- Other
- Recovered from prior therapy
- No prior epidermal growth factor receptor inhibitor therapy
- No other concurrent antineoplastic or antitumor therapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00118261
Start Date
March 1 2005
End Date
January 1 2011
Last Update
September 3 2012
Active Locations (3)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
2
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
3
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122