SWOG clinical trial number
S0717

A Phase I and A Randomized Phase II Study of Maximal Angiogenic Blockade in Advanced Renal Carcinoma: Bevacizumab (NSC-704865) with or without MEDI-522 (NSC-719850)

Closed
Phase
Accrual
4%
Abbreviated Title
Advanced Renal
Activated
06/15/2008
Closed
04/01/2009
Participants
Limited: Institutions Listed on the Title Page

Research committees

Genitourinary Cancer

Treatment

Bevacizumab MEDI-522

Eligibility Criteria Expand/Collapse

Histologic or cytologic confirmed RCC, metastatic or unresectable. Must have rec'd prior tx for met or unresect dx w/sunitinib or sorafenib. No more than 2 prior systemic regimens for RCC (incl adj tx), but recovered from all assoc tox and at least 14 days elapsed since completion of prior tx. Measurable dx assessed w/in 28 days prior to reg. No invasive procedures per Section 5.5. Prior RT to < 25% of bone marrow ok, but at least 28 days must have elapsed and pt must have recovered from assoc tox. No brain mets </= 6 mos. May be on full dose anticoagulation w/warfarin provided INR 2-3 obtained w/in 28 days. May be rec'g low molecular wt heparin. No clinically relevant bleeding diathesis or coagulopathy except per Section 5.8. Urine protein screened for UPC ration w/in 28 days prior to reg. Controlled blood pressure. No arterial thrombosis, unstable angina, MI or CVA w/in 6 mos prior to reg. No NYHA >\= Class II CHF. No unstable, symptomatic arrhythmia req'g medication. No clinically significant vascular dx. Must be offered opportunity to consent for specimen banking. Zubrod PS 0-1. Not pregnant nor nursing. Agree to use effective contraceptive method. No known hypersensitivity to Chinese hamster ovary cell products nor recombinant human antibodies. No serious or non-healing wound, ulcer or bone fracture. No hx of abdominal fistula, GI perforation or intra-abdominal abscess w/in 28 days prior to reg. No other prior malignancy.

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SWOG Clinical Trial Number
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Research Committee(s)
Genitourinary Cancer
Activated
08/14/2023
Accrual
7%
Open
Phase
SWOG Clinical Trial Number
S2200