S0718 Pazopanib and Temsirolimus in Treating Patients With Advanced Solid Tumors

NCT00788580 | Withdrawn Phase 1

• 2 other identifiers: S0718SWOG-S0718
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Pazopanib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib may also blocking blood flow to the tumor. Giving pazopanib together with temsirolimus may be an effective treatment for advanced solid tumors. PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when given together with pazopanib in treating patients with advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

• Safety as assessed by NCI CTCAE v3.0

• Feasibility of the drug combination

• Maximum tolerated dose of temsirolimus in combination with pazopanib

Secondary Outcomes (3)

• Pharmacokinetics of temsirolimus alone and in combination with pazopanib

• Relevant biological markers

• Objective response as assessed by RECIST criteria

Interventions

pazopanib hydrochloride DRUG

temsirolimus DRUG

immunoenzyme technique PROCEDURE

laboratory biomarker analysis PROCEDURE

pharmacological study PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Cytologically or pathologically verified cancer that is of advanced stage and for which there is no effective therapy * No lymphoma * Measurable or nonmeasurable disease * Previously irradiated (whole brain or gamma knife) brain metastases allowed provided there is no requirement for corticosteroids or anticonvulsants PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL (without transfusions) * AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver metastases present) * Bilirubin normal * Serum creatinine ≤ 1.5 times ULN OR measured creatinine clearance OR calculated creatinine clearance ≥ 60 mL/min * QTC interval \< 480 msec on baseline ECG OR average QTC \< 480 msec on baseline plus 2 additional screening ECG's * Fasting cholesterol \< 350 mg/dL * Fasting triglycerides \< 400 mg/dL * No uncontrolled hypertension, arterial thrombotic event, or bleeding on therapeutic anticoagulation with warfarin or heparin (including low molecular weight heparin) within the past 6 months * Able to swallow enteral medications * No feeding tubes * No intractable nausea or vomiting * No gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn, ulcerative colitis) * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin analogs (e.g., sirolimus and everolimus) * No known HIV positivity * No uncontrolled intercurrent illness including, but not limited to, the following: * Ongoing or serious active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Serious cardiac arrhythmia * History of myocardial infarction * Cerebrovascular accident within 3 months of study entry * Uncontrolled diarrhea * Psychiatric illness or social situation that would limit compliance with study requirements * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception, including barrier methods * Willing to undergo pharmacokinetic (PK) sampling and blood submission for PK and translational medicine studies PRIOR CONCURRENT THERAPY: * Recovered from all prior therapy * No prior pazopanib hydrochloride or temsirolimus * More than 28 days since prior major surgery, chemotherapy, biologic therapy, or immunotherapy * More than 28 days since prior investigational agents * At least 14 days since prior radiotherapy * No concurrent rapamycin (sirolimus) * No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), CYP3A4 inducers (e.g., rifampin or St. John's wort), or CYP3A4 inhibiting agents or substrates (e.g., ketoconazole, diltiazem, or verapamil) * No concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of this cancer while on this protocol * No live vaccines * Luteinizing-hormone releasing-hormone agonists allowed * Concurrent prophylactic warfarin (≤ 1 mg/day) allowed * Concurrent bisphosphonate or erythropoietin or its analogue allowed, if deemed appropriate by the treating physician

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

temsirolimus; Immunoenzyme Techniques

Intervention Hierarchy (Ancestors)

Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Claire F. Verschraegen, MD

  University of New Mexico Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 8, 2008
• First Posted: November 11, 2008
• Last Updated: March 6, 2015

Record last verified: 2015-03