Everolimus and Vatalanib in Treating Patients With Advanced Solid Tumors (NCT00655655) | Clinical Trial Compass
CompletedPhase 1
Everolimus and Vatalanib in Treating Patients With Advanced Solid Tumors
United States96 participantsStarted 2004-12
Plain-language summary
RATIONALE: Everolimus and vatalanib 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. Giving everolimus together with vatalanib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus and vatalanib in treating patients with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic proof of cancer that is now unresectable (solid tumors, excluding lymphoma)
* Ability to provide informed consent
* Willingness to return to Mayo Clinic Rochester for follow up
* Life expectancy \>= 12 weeks
* Prior anti-VEGF therapy allowed
* Cohort IIA: Patients meeting other eligibility criteria, regardless of histopathologic diagnosis; tumor that is amenable to biopsy; willingness to provide blood specimens, undergo DCE-MRI, and undergo brachial artery ultrasound measurements as required by the protocol
* The following laboratory values obtained =\< 14 days prior to registration:
Negative for proteinuria based on dip stick reading OR, if documentation of +1 result for protein on dip stick reading, then total urinary protein =\< 500 mg and measured creatinine clearance (CrCl) \>= 50 mL/min from a 24-hour urine collection
* Cohort IIB: Patients meeting other eligibility criteria AND with pathologic diagnosis of metastatic kidney cancer, neuroendocrine carcinoma, melanoma, and NSCLC; willingness to provide blood specimens required and undergo brachial artery ultrasound measurements
* The following laboratory values obtained =\< 14 days prior to registration:
ANC \>= 1500/uL; Hgb \>= 9 g/dL; PLT \>= 100,000/uL; Total bilirubin =\< 1.5 x upper limit of normal (ULN); AST =\< 3 x ULN or AST =\< 5 x ULN if liver involvement; Creatinine =\< 1.5 x ULN; INR =\< 1.4 (Cohort IIA only)
Exclusion Criteria:
* Any of the following prior therapies: Fu…
What they're measuring
1
Maximum tolerated dose of everolimus and vatalanib (Cohort I) (Closed to enrollment as of 12/6/06)
Timeframe: Up to 28 days post treatment cycle
2
Toxicity associated with everolimus and vatalanib (Cohort I) (Closed to enrollment as of 12/6/06)
Timeframe: Up to 28 days post treatment cycle
3
Therapeutic antitumor activity of everolimus and vatalanib (Cohort I) (Closed to enrollment as of 12/6/06)
Timeframe: Up to 28 days post treatment cycle
4
Recommended phase II dose (RP2D) of everolimus and vatalanib (Cohort I) (Closed to enrollment as of 12/6/06)
Timeframe: After MTD (maximum tolerate dose) is determined from Phase I
5
Biological activity and therapeutic antitumor activity of everolimus and vatalanib when given at the MTD/RPTD (Cohort II)
Timeframe: Post treatment cycle
6
Evaluation of pharmacogenetic, metabolic, and clinical markers that may predict hypertension induced by anti-VEGF therapy (Cohort II)
Timeframe: Day 1 and 14 of Cycle 1 of treatment
7
Efficacy outcomes in patients with metastatic kidney cancer, neuroendocrine carcinoma, non-small cell lung cancer, or melanoma (Cohort II)