Status:
COMPLETED
Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney, Colorectal, Head and Neck, Pancreatic, or Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This randomized phase I/II trial studies the side effects, best way to give, and best dose of erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and cetuximab together w...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of erlotinib when combined with cetuximab in patients with metastatic or unresectable renal cell, colorectal, head and neck, pancreat...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- One of the following histologically confirmed diagnoses:
- Renal cell cancer
- Clear cell histology
- Metastatic or unresectable disease AND meets 1 of the following criteria:
- Recurrent disease
- Refractory to interleukin-2 (IL-2)- or interferon-based therapy
- Previously untreated AND not a candidate for IL-2-based therapy
- Colorectal, head and neck, pancreatic, or non-small cell lung cancer
- Metastatic or unresectable disease
- Progression after prior standard treatment
- No evidence of CNS disease, including the following (part 2 only):
- Primary brain tumor
- Brain metastases
- Paraffin embedded tumor blocks available
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- Absolute neutrophil count ≥ 1,500 mm\^3
- Platelet count ≥ 100,000 mm\^3
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastasis is present)
- PTT and INR ≤ 1.5, unless receiving full-dose warfarin (part 2 only)
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 60 mL/min
- Calcium \< 10 mg/dL (hypocalcemic agents allowed)
- No proteinuria\*
- Protein \< 1 g on 24-hour urine collection\*
- No unstable angina pectoris
- No cardiac arrhythmia
- No symptomatic congestive heart failure
- None of the following are allowed for part 2:
- Myocardial infarction within the past 6 months
- New York Heart Association class II-IV heart disease
- Serious cardiac arrhythmia requiring medication
- Peripheral vascular disease ≥ grade II
- Recent history of cerebrovascular accident
- Uncontrolled hypertension (blood pressure ≥ 150/85 mm Hg despite medication)
- Other clinically significant cardiovascular disease
- No gastrointestinal (GI) tract disease resulting in an inability to take oral medication
- No GI tract disease resulting in a requirement for IV alimentation
- No active peptic ulcer disease
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (part 2 only)
- No ongoing or active infection
- No active infection requiring parenteral antibiotics (part 2 only)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study treatment
- No significant traumatic injury within the past 28 days (part 2 only)
- No history of abnormalities of the cornea (e.g., dry eye syndrome, Sjögren's syndrome, or congenital abnormality \[e.g., Fuch's dystrophy\])
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast or cervix
- No psychiatric illness or social situation that would preclude study compliance
- No serious or non-healing wound ulcer or bone fracture (part 2 only)
- No other uncontrolled illness
- See Disease Characteristics
- More than 4 weeks since prior immunotherapy
- No prior cetuximab
- No prior bevacizumab
- Concurrent epoetin alfa or darbepoetin alfa allowed
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- More than 4 weeks since prior radiotherapy
- No prior surgical procedures affecting absorption
- Prior nephrectomy or resection of metastatic lesions allowed provided patient has fully recovered
- More than 7 days since prior core biopsy\*
- More than 28 days since prior major surgery or open biopsy\*
- No concurrent major surgery\*
- Recovered from all prior therapy
- No prior erlotinib
- Concurrent bisphosphonates allowed
- Concurrent full-dose anticoagulants allowed provided the following criteria are met (part 2 only):
- In-range INR (usually between 2 and 3) AND on a stable dose of warfarin or low molecular weight heparin
- No active bleeding
- No pathological conditions that carry a high risk of bleeding (e.g., tumor involving major vessels or varices)
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00101348
Start Date
January 1 2005
End Date
May 1 2008
Last Update
June 11 2014
Active Locations (1)
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1
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229