Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery

Conditions

• Recurrent Renal Cell Carcinoma
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer
• Type 1 Papillary Renal Cell Carcinoma
• Type 2 Papillary Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib Hydrochloride — DRUG
  150 mg (1 tablet) by mouth on days 1-28, once daily, until disease progression
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Tivantinib — DRUG
  360 mg (3 tablets) by mouth, Twice daily (720 mg total daily dose) on days 1-28, until disease progression

Study Details

This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

First listed

Sep 20, 2012

Start date

Aug 20, 2012

Status verified

Dec 2018

Primary completion

Apr 30, 2017

Completion

Apr 30, 2017

Study Design

Enrollment

55 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (tivantinib)
  Patients receive tivantinib PO BID on days 1-28.
• Experimental: Arm II (tivantinib and erlotinib hydrochloride)
  Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28.

Primary Outcome Measure

Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 3 years ]

Locations (214)

Find similar trials in Tucson, AZ

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