Status:
COMPLETED
Everolimus, Fluorouracil, Leucovorin, Panitumumab, and Oxaliplatin in Treating Patients With Tumors That Did Not Respond to Treatment
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouraci...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of everolimus in combination with sequential fluorouracil (5-FU) and leucovorin calcium, panitumumab, modified 5-FU, leucovorin calcium,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant solid tumor
- Advanced or unresectable disease
- No standard therapeutic option available
- Evaluable disease (according to RECIST criteria) that has not been previously irradiated
- Prior radiotherapy to the marker lesion(s) allowed provided there is evidence of progression since radiotherapy
- Brain metastases allowed provided the following criteria are met:
- CNS-directed treatment was given and was completed \> 3 months ago
- CNS disease has been clinically and radiographically stable for ≥ 8 weeks
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤ 1.2 mg/dL
- Transaminases ≤ 5 times upper limit of normal (ULN)
- Magnesium ≥ lower limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 24 weeks (females) or for 4 weeks (males) after completion of study therapy
- Willing to avoid pregnancy for 3 months after completion of study therapy
- No neuropathy ≥ grade 2
- No concurrent life-threatening acute medical illness
- No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- No active bleeding diathesis
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior major surgery, radiotherapy (including radiotherapy involving the abdomen or spine), chemotherapy, or other systemic anticancer therapy and recovered
- At least 4 weeks since prior investigational drugs
- No concurrent CYP3A4 inducers or inhibitors that cannot be substituted by a different agent
- No concurrent oral anti-vitamin K medication (except for low-dose warfarin)
- No concurrent colony stimulating factors during the first course of treatment
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00610948
Start Date
March 1 2008
End Date
January 1 2016
Last Update
May 4 2017
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295