Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Trial of the mTOR Inhibitor RAD001 in Combination With VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 in Patients With Advanced Solid Tumors
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.
OBJECTIVES:
I. To determine the dose limiting toxicity (DLT) and maximally tolerated dose (MTD) of RAD001
and once daily PTK787 when given in combination. (Cohort IA) II. To describe the toxicities
associated with the combination of RAD001 and once daily PTK787. (Cohort IA) III. To evaluate
the therapeutic antitumor activity of the combination of once daily PTK787 with RAD001.
(Cohort IA) IV. To determine the dose limiting toxicity (DLT) and maximally tolerated dose
(MTD) of RAD001 and twice daily PTK787 when given in combination. (Cohort IB) V. To describe
the toxicities associated with the combination of RAD001 and twice daily PTK787. (Cohort IB)
VI. To evaluate the therapeutic antitumor activity of the combination of twice daily PTK787
with RAD001. (Cohort IB) VII. To determine the MTD-Recommended Phase 2 Dose (RP2D) based on
the MTD for Cohorts IA and IB. (Cohorts IA & IB) VIII. To investigate the biological activity
of the combination of PTK787 with RAD001 at the MTD-RP2D. (Cohort II) IX. To evaluate the
therapeutic antitumor activity of the combination of PTK787 with RAD001 at the MTD-RP2D.
(Cohort II) X. To evaluate pharmacogenetic, metabolic and clinical markers that may predict
for hypertension induced by anti-VEGF therapy. (Cohort II) XI. To obtain pilot data on
efficacy outcomes in patients with metastatic kidney cancer, neuroendocrine cancer, NSCLC or
melanoma. (Cohort II)
OUTLINE:
Patients are assigned to 1 of 4 cohorts, according to their disease (cohort IA, IB, or IIA
[any histopathologic diagnosis] vs cohort IIB [metastatic kidney cancer, neuroendocrine
cancer, melanoma, or non-small cell lung cancer). Patients are initially enrolled into
cohorts IA and IB until the maximum tolerated dose (MTD) and recommended phase II dose (RP2D)
are determined. Once the MTD/RP2D of everolimus and vatalanib are determined, subsequent
patients are enrolled and treated in expansion cohorts IIA or IIB.
Cohorts 1A or 1B (dose escalation cohorts; closed to enrollment as of 12/6/06): Patients
receive oral vatalanib once (cohort 1A) or twice (cohort 1B) daily on days 1-28 and oral
everolimus once daily on days 15-28 of course 1. For all subsequent courses, patients receive
oral vatalanib once (cohort 1A) or twice (cohort 1B) daily and oral everolimus once daily on
days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
Cohort IIA (expansion cohort treated at the MTD/RP2D): Patients receive oral everolimus once
daily for 14 days followed by a 7-day rest period. Patients then receive oral vatalanib twice
daily on days 1-28 and oral everolimus once daily on days 15-28 of course 1. For all
subsequent courses, patients receive oral vatalanib twice daily and oral everolimus once
daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Cohort IIB (expansion cohort treated at the MTD/RP2D): Patients receive oral vatalanib twice
daily on days 1-28 and oral everolimus once daily on days 15-28 of course 1. For all
subsequent courses, patients receive oral vatalanib twice daily and oral everolimus once
daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months.
;
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