SWOG clinical trial number
S1107

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

Closed
Phase
Accrual
71%
Abbreviated Title
Papillary Renal, ARQ 197 +/- Erlotinib, Ph II
Activated
08/20/2012
Closed
05/29/2014
Participants
NCORP, Members, Medical Oncologists, Surgeons, CTSU, Affiliates

Research committees

Genitourinary Cancer

Treatment

Erlotinib ARQ 197

Eligibility Criteria Expand/Collapse

Pt must have histo or cyto conf papillary RCC which is metastatic or locally adv & unresectable. Mixed histologies ok if >/= 50% pap. Pt must have measurable dx. Prior resection ok, but 28 days must have lapsed & pt recovered. Pts w/hx of brain mets who are asymptomatic and have not rec'd steroid tx w/in 14 days prior to reg eligible. Anti-seizure meds allowed provided non-enzyme inducing. Pts may have rec'd up to one prior systemic tx for adv or met RCC but 21 days must have lapsed (42 for nitrosoureas or mitomycin C). No prior MET inhibitor or erlotinib. Prior RT ok if measurable dx outside RT port and 21 days lapsed. Must be offered specimen banking. Zubrod 0-2. WBC >/=2000, ANC >/= 1000, PLT >/=75000, bili </= 1.5 ULN, SGOT & SGPT </= 1.5 ULN, creatinine </= 2 x ULN w/in 14 days prior to reg. Na, K & Ca w/in 14 days prior to reg. Prestudy physical exam & med hx w/in 28 days prior to reg. Must not have hx of corneal diseases in 5.13. Not known to be HIV+ and rec'g anti-retroviral tx. Able to take oral meds. No GI disease req'g IV alimentation, prior surgery affecting absorption, active peptic ulcer disease. Not rec'g nor planning to receive other inv agents. Not pregnant or nursing and agreed to use effective contraception method. No prior malignancy.

Publication Information Expand/Collapse

2017

Parallel (Randomized) Phase II Evaluation of Tivantinib (ARQ197) and Tivantinib in Combination with Erlotinib in Papillary Renal Cell Carcinoma: SWOG S1107

P Twardowski;C Tangen;X Wu;MR Plets;ER Plimack;N Agarwal;NJ Vogelzang;J Wang;J Wang;S Tao;I Thompson;P Lara Kidney Cancer Nov 27;1(2):123-132

PMid: PMID30334014 | PMC number: PMC6179121

Exome Sequencing of Tumor Tissue Samples Collected from Patients Participating in SWOG S1107 “Parallel (Randomized) Phase II Evaluation of Tivantinib (ARQ-197) and Tivantinib in Combination with Erlotinib in Papillary Renal Cell carcinoma (pRCC)

P Twardowski;X Wu;CM Tangen;E Plimack;N Agarwal;M Plets;N Vogelzang;J Wang;S Tao;IM Thompson;PN Lara Annals of Oncology Sep; 28:Supplement abst. 910P, p.323; ESMO Annual Meeting (September 8-12, 2017, Madrid, Spain), poster

2015

SWOG 1107: Parallel randomized phase II evaluation of tivantinib (ARQ-197) and tivantinib in combination with erlotinib in patients (pts) with advanced papillary renal cell carcinoma (pRCC)

P Twardowski;M Plets;ER Plimack;N Aggarwal;C Tangen;N Vogelzang;IM Thompson;PN Lara Journal of Clinical Oncology 33:5s (suppl; abstr 4523); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster discussion;

2014

Papillary renal cell carcinoma: current progress and future directions

P Twardowski;PC Mack;P Lara Clinical Genitourinary Cancer 12(2):74-79

PMid: PMID24629521 | PMC number: n/a - review article

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