NCI Community Oncology Research Program - Protocol Summary
SWOG S1500 - "A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)”
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
GU Clinical Trial
CANCER TYPE: Renal
RESEARCH BASE: SWOG
NCT NUMBER: NCT02761057
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
UPDATED ON 04/17/2019 (16:55:50)
Stage IV, type I or II papillary renal carcinoma, cabozantinib vs. crizotinib vs. savolitinib vs. sunitinib
Arms 3 and 4 are permanently closed to accrual.
Patients must have tissue available and be willing to submit for independent pathologic review in order to classify type I versus type II papillary disease.
Treatment (Supplied drugs: sunitinib, cabozantinib, crizotinib, savolitinib)
Sunitinib 50mg PO, daily on days 1-28, hold days 29-42, until progression or toxicity
Cabozantinib 60mg PO, daily on days 1-42, until progression or toxicity
1 Cycle = 42 days
- Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection.
- Patients must also have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension.
- Patients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible.
- Patients must not have cavitating pulmonary lesions.
- Patients may have received prior surgery. At least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery.
- Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor FDA-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib).
- Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port.
- Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipravavir/RIT, or voriconazole,); strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); potent inhibitors of CYP1A2 (e.g. ciprofloxacin); and/or drugs known to be CYP3A4 substrates with a narrow therapeutic range (e.g., diergotamine, ergotamine) within 14 days prior to randomization.
- 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 - 1 (see Section 10.4).
- Patients must have adequate hematologic function as documented by a WBC ≥ 2,000/mcL, an ANC ≥ 1,000/mcL, and a platelet count ≥ 75,000/mcL. These tests must be obtained within 28 days prior to registration.
- Patients must have adequate hepatic function as evidenced by serum bilirubin ≤ 1.5 x institutional upper limits of normal (ULN). Serum transaminase (SGOT/AST and SGPT/ALT) must be ≤ 2.5 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. These tests must be obtained within 28 days prior to registration.
- Serum creatinine must be ≤ 2 x the institutional ULN OR creatinine clearance (either measured or calculated) must be > 30 mL/min and obtained within 28 days prior to registration.
- Patients must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] Class III [moderate] or Class IV [severe]) at the time of registration.
- Baseline urinalysis should show urine protein < 3+ and must be obtained within 28 days prior to registration. If urine protein is 3+ or greater, then urine protein by 24 hour collection must show less than 3 grams of protein.
- Patients must not have inadequately controlled hypertension. Patients must have documented blood pressures of SBP < 150 and DBP < 90 within 14 days of starting randomization.
- Patients must be able to take oral medications (i.e., swallow pills whole).
- Patients must not have had any clinically-significant GI bleeding within 6 months prior to registration and patients must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula. Examples of this include (but are not limited to) Crohn’s disease or tumor with transmural extension through the gastrointestinal lining.
- Patients must not have had hemoptysis of ≥ 0.5 teaspoon (2.5 ml) of red blood within 3 months prior registration.
- Patients must not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior to registration.
- Patient’s baseline imaging must not indicate the presence of tumor invading or encasing any major blood vessels.
- Patients must not have any unresolved wounds from previous surgery.
- Albumin, alkaline phosphatase, bicarbonate, BUN, chloride, glucose, phosphorus, and total protein must be assessed within 28 days of registration.
- 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 3 years. Men receiving active surveillance for prostate cancer may also be enrolled.
- Due to the unknown effects of the study drugs, patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for three months after last dose of study drug.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cabozantinib, crizotinib, savolitinib or sunitinib.
- Patients must be ≥ 18 years of age.