Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with sunitinib and to see how well they work in treating patients with unresectable or metastatic kidney cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride; Sunitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma with a component of clear cell or papillary carcinoma

• Unresectable or metastatic disease (radiologically or clinically confirmed)

• Measurable disease (≥ 1 site)

• No known brain metastasis that has not been adequately treated with radiotherapy and/or surgery

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• No grade 3 hemorrhage within the past 4 weeks

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times ULN (< 5 times ULN if due to underlying disease)

• No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

• Creatinine ≤ 1.5 times ULN

• None of the following cardiovascular conditions within the past 12 months:

• Myocardial infarction

• Severe/unstable angina

• Coronary/peripheral artery bypass graft

• Symptomatic congestive heart failure

• Cerebrovascular accident or transient ischemic attack

• Pulmonary embolism

• Ongoing cardiac dysrhythmia ≥ grade 2

• Atrial fibrillation of any grade

• Prolongation of the corrected QT (QTc) interval to > 450 msec for males or to > 470 msec for females

• Left Ventricular Ejection Fraction (LVEF) normal by Multigated Acquisition (MUGA) or echocardiogram

• No hypertension uncontrolled with medical therapy

• No other active malignancy within the past 5 years except basal cell skin cancer or cervical carcinoma in situ

• No uncontrolled adrenal insufficiency

• No uncontrolled hypothyroidism

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)

• No impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs

• No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 4 weeks since prior major surgery

• More than 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C)

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to > 25% of the bone marrow

• More than 28 days since prior investigational agents

• No prior sunitinib malate

• No prior anti-epidermal growth factor receptor therapy (e.g., erlotinib hydrochloride, panitumumab, cetuximab, or gefitinib)

• No concurrent therapeutic warfarin

• Low-dose oral warfarin ≤ 2 mg daily for deep vein thrombosis prophylaxis is allowed after the maximum tolerated dose of erlotinib hydrochloride is determined

• No concurrent Hypericum perforatum (St. John's wort)

• No concurrent chemotherapy or biologic therapy

• No other concurrent anticancer therapy

• No other concurrent investigational agents