Bevacizumab With or Without MEDI-522 in Treating Patients With Unresectable or Metastatic Kidney Cancer

NCT00684996 | Terminated Phase 1 Results

• 4 other identifiers: NCI-2009-01099CDR0000596555S0717U10CA032102
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief Summary

This phase I/randomized phase II trial is studying the side effects and best dose of bevacizumab and to see how well it works when given together with or without MEDI-522 in treating patients with unresectable or metastatic kidney cancer. Monoclonal antibodies, such as bevacizumab and MEDI-522, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab and MEDI-522 may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without MEDI-522 in treating kidney cancer.

Conditions

Recurrent Renal Cell Cancer; Renal Cell Carcinoma; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (5)

• Maximum Tolerated Dose of Bevacizumab , Based on Incidence of Dose-limiting Toxicity (DLT) Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)

  Up to 8 weeks

• Progression-free Survival (Phase II)

  Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

  From date of registration to date of first observation of progressive disease, systemic deterioration, or death due to any cause, assessed up to 3 years

• Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 (Phase II)

  Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

  Up to 3 years

• Overall Survival (Phase II)

  Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

  From date of registration to date of death due to any cause, assessed up to 3 years

• Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST), Including Confirmed and Unconfirmed Complete and Partial Responses (Phase II)

  Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of nonmeasurable disease. No new lesions.

  Up to 3 years

Secondary Outcomes (1)

• Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

  Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years

Study Arms (2)

Phase II Arm I

ACTIVE COMPARATOR

Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.

Biological: bevacizumab

Phase II Arm II

ACTIVE COMPARATOR

Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.

Drug: etaracizumab; Biological: bevacizumab

Interventions

etaracizumab DRUG

Given IV

Also known as: Abegrin, humanized monoclonal antibody MEDI-522, MEDI-522, monoclonal antibody anti-alpha V beta 3 integrin MEDI-522

Phase II Arm II

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Phase II Arm I; Phase II Arm II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Criteria: * Histologically or cytologically confirmed renal cell carcinoma * Metastatic or unresectable disease * Must have received prior sunitinib malate or sorafenib tosylate for metastatic or unresectable disease * Measurable disease * No soft tissue disease that has been irradiated within the past 2 months * More than 6 months since prior and no concurrent treated or untreated brain metastases * Stable, treated brain metastases allowed provided they remained stable for more than 6 months * Patients with clinical evidence of brain metastases must have a negative brain CT or MRI scan for metastatic disease * Zubrod performance status 0-1 * Urine protein:creatinine ratio =\< 0.5 OR urine protein \< 1,000 mg by 24-hour collection * Not be pregnant or nursing * Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy * No serious or non-healing wound, ulcer, or bone fracture * No clinically relevant bleeding diathesis or coagulopathy * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days * No significant traumatic injury within the past 28 days * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * No other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, 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 * No New York Heart Association class II-IV congestive heart failure * No unstable symptomatic arrhythmia requiring medication * Chronic, controlled arrhythmias (e.g., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed * None of the following cardiovascular conditions within the past 6 months: Arterial thrombosis, Unstable angina, Myocardial infarction, Cerebrovascular accident * Must have controlled blood pressure, defined as systolic blood pressure (BP) =\< 160 mm Hg and/or diastolic BP =\< 90 mm Hg * More than 7 days since prior core biopsy * At least 14 days since completion of prior therapy and recovered * At least 28 days since prior radiotherapy and recovered * No prior radiotherapy to \>= 25% of bone marrow * No more than two prior systemic regimens for renal cell carcinoma (including adjuvant treatment) * No prior bevacizumab or humanized monoclonal antibody MEDI-522 * No major surgical procedure or open biopsy within the past 28 days * No concurrent need for a major surgical procedure * Concurrent full-dose anticoagulation with warfarin allowed provided INR is between 2-3 * Concurrent low molecular weight heparin allowed * No clinically significant vascular disease (e.g., aortic aneurysm or history of aortic dissection)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (5)

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

University of California at Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

SWOG

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

etaracizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Christopher Ryan

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2008
• First Posted: May 28, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 15, 2014
• Results First Posted: January 14, 2014

Record last verified: 2013-04

Locations

US (5)