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

Not Recruiting

Trial ID: NCT01688973


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.

Official Title

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor


Inclusion Criteria:

   - Patients must have histologically or cytologically confirmed papillary histology renal
   cell carcinoma which is metastatic, or locally advanced and unresectable; mixed
   histologies will be allowed provided that they contain >= 50% of the papillary

   - Patients must have measurable disease, defined as at least one lesion that can be
   accurately measured in at least one dimension; x-rays, scans or physical examinations
   used for tumor measurement must have been completed within 28 days prior to
   registration; x-rays, scans or physical examinations for non-measurable disease must
   have been completed within 42 days prior to registration; all disease must be assessed
   and documented on the Baseline Tumor Assessment form

   - Patients with metastatic disease who have a resectable primary tumor and are deemed a
   surgical candidate may have undergone resection; at least 28 days must have elapsed
   since surgery and patient must have recovered from any adverse effects of surgery

   - Patients with a history of brain metastases who are asymptomatic and have not received
   steroid therapy in the 14 days prior to registration are eligible; anti-seizure
   medications are allowed provided they are non-enzyme inducing (e.g. topiramate,
   levetiracetam, gabapentin)

   - Patients may have received up to one prior systemic therapy for advanced or metastatic
   renal cell carcinoma; patients must not have received a MET inhibitor or erlotinib as
   prior therapy; at least 21 days must have elapsed since completion of prior systemic
   therapy, 42 days for nitrosoureas or mitomycin C; patients must have recovered from
   all associated toxicities at the time of registration

   - Patients may have received prior radiation therapy, but must have measurable disease
   outside the radiation port; at least 21 days must have elapsed since completion of
   prior radiation therapy; patients must have recovered from all associated toxicities
   at the time of registration

   - Patients must not be receiving or planning to receive any other investigational agents

   - Patients must have a complete physical examination and medical history within 28 days
   prior to registration

   - Patients must have a Zubrod performance status of 0-2

   - White blood cell (WBC) >= 2,000/mcL

   - Absolute neutrophil count (ANC) >= 1,000/mcL

   - Platelet count >= 75,000/mcL

   - Serum bilirubin =< 1.5 x institutional upper limits of normal (ULN)

   - Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and
   serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) must be =<
   1.5 x the institutional ULN unless the liver is involved with the tumor, in which case
   serum transaminase (SGOT/SGPT) must be =< 5 x the institutional ULN

   - Serum creatinine must be =< 2 x the institutional ULN

   - Sodium, potassium and calcium must be obtained within 14 days prior to registration

   - Patients with a known history of the following corneal diseases are not eligible: dry
   eye syndrome, Sjogren's syndrome, keratoconjunctivitis sicca, exposure keratopathy,
   Fuchs' dystrophy or other active disorders of cornea

   - Patients known to be human immunodeficiency virus (HIV)-positive and receiving
   combination anti-retroviral therapy are not eligible

   - Patients must be able to take oral medications; patients must not have
   gastrointestinal tract disease resulting in an inability to take oral medication or a
   requirement for intravenous (IV) alimentation, prior surgical procedures affecting
   absorption, or active peptic ulcer disease; patients with intractable nausea or
   vomiting are not eligible

   - Patients must not be pregnant or nursing; women/men of reproductive potential must
   have agreed to use an effective contraceptive method; a woman is considered to be of
   "reproductive potential" if she has had menses at any time in the preceding 12
   consecutive months; in addition to routine contraceptive methods, "effective
   contraception" also includes heterosexual celibacy and surgery intended to prevent
   pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
   bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
   previously celibate patient chooses to become heterosexually active during the time
   period for use of contraceptive measures outlined in the protocol, he/she is
   responsible for beginning contraceptive measures

   - No other prior malignancy is allowed except for the following: adequately treated
   basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
   stage I or II cancer from which the patient is currently in complete remission, or any
   other cancer from which the patient has been disease-free for 5 years

   - Patients must be offered the opportunity to participate in specimen banking for future
   translational medicine studies

   - All patients must be informed of the investigational nature of this study and must
   sign and give written informed consent

   - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
   treating institution's identity is provided in order to ensure that the current
   (within 365 days) date of institutional review board approval for this study has been
   entered in the system


drug: tivantinib

drug: erlotinib hydrochloride

other: laboratory biomarker analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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