Status:
COMPLETED
Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Colon Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and the best dose of lenalidomide when given together with cetuximab in treating patients with colorectal cancer or head and neck cancer that has spread to ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose of lenalidomide when given in combination with cetuximab in patients with advanced colorectal or squamous cell head and neck cancer. SE...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; eligible malignancies include: colorectal cancer KRAS wild-type and squamous cell head and neck cancer
- No curative intent therapy available; there is no limit on prior number of therapies; prior epidermal growth factor receptor (EGFR)-directed therapy (tyrosine kinase inhibitors and monoclonal antibodies - including cetuximab, panitumumab, or investigational EGFR directed monoclonal antibodies) will be allowed in the phase I dose escalation; patients who have received monoclonal antibody therapy must be off all monoclonal antibodies four weeks (28 days) prior to study treatment; no chemotherapy within 28 days of trial medication
- There will be an expansion cohort for colorectal cancer patients only; for the expansion cohort, there is no limit on prior chemotherapy; the colorectal expansion cohort will include patients with cetuximab or panitumumab-resistant or refractory disease (progression during cetuximab/panitumumab therapy or within 3 months of cetuximab/panitumumab therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \> 60%)
- Life expectancy of greater than 3 months
- Leukocytes \> 3,000/mcL
- Absolute neutrophil count \> 1,500/mcL
- Platelets \> 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x institutional upper limit of normal
- Creatinine clearance \> 60 mL/min/1.73 m\^2 as calculated using modified Cockcroft-Gault formula
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
- Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
- All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
- Able to take aspirin (81 or 325 mg) daily for prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)
Exclusion
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (\>= grade 3) due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- Uncontrolled brain metastases; patients who have received definitive therapy, including radiation, and are not requiring ongoing medical therapy (i.e. steroids) for brain metastases will be allowed
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide or cetuximab or other agents used in study
- Patients with a recent history of deep vein thrombosis (DVT)/pulmonary embolism (PE) requiring therapy (within 3 months)
- Patients with history of toxicity \>= grade 3 with prior EGFR directed therapy
- Patient with confirmed history of interstitial lung disease
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with either agent
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Key Trial Info
Start Date :
February 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01254617
Start Date
February 10 2011
End Date
January 29 2014
Last Update
March 13 2020
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210