Bevacizumab in Treating Patients With Advanced Solid Tumors

NCT00416637 | Completed Phase 1

• 4 other identifiers: Pro00008011DUMC-4907-05-6R2GENENTECH-DUMC-4907-05-6R2CDR0000449969
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor . PURPOSE: This phase I trial is studying how well bevacizumab works in treating patients with advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

Bevacizumab (Avastin)

EXPERIMENTAL

Bevacizumab given and then BP checked and skin biopsies obtained.

Biological: Bevacizumab (Avastin)

Interventions

Bevacizumab (Avastin) BIOLOGICAL

Bevacizumab (Avastin)

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Metastatic or unresectable disease * Standard curative or palliative measures do not exist or are no longer effective OR treatment with standard chemotherapy plus bevacizumab is appropriate\* NOTE: \*It must be judged clinically appropriate by the treating physician to delay combination treatment for the 6 weeks needed for study participation * Patients with squamous cell non-small cell lung cancer are ineligible PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * AST/ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases are present) * Creatinine clearance ≥ 50 mL/min * No proteinuria at baseline * Patients with ≥ 1+ proteinuria during screening should undergo a timed 12- or 24-hour urine collection, which must be an adequate collection and must demonstrate \< 500 mg protein/24 hr to be eligible for the study * Not pregnant or nursing * No nursing for ≥ 4 months after completion of study treatment * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 4 months after completion of study treatment * No arterial thromboembolic events within the past 6 months, including any of the following: * Transient ischemic attack * Cerebrovascular accident * Unstable angina * Myocardial infarction * Clinically significant peripheral vascular disease * No venous thromboembolic event within the past 3 months * No clinically significant cardiovascular disease * No uncontrolled hypertension * No New York Heart Association class II or greater congestive heart failure * No serious cardiac arrhythmia requiring medication * Atrial or supraventricular tachycardias that are well controlled with beta blockers or calcium channel blockers are allowed * Chronic pacemakers allowed * No presence of bleeding diathesis or coagulopathy * No significant traumatic injury within the past 4 weeks * No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications PRIOR CONCURRENT THERAPY: * No administration of nitrates within the past week * At least 2 weeks since prior and no concurrent antihypertensive agent(s) * Must have stable blood pressure (BP) (BP \< 160/100 mm Hg) within the past 2 weeks * Must be asymptomatic within the past 2 weeks * No open biopsy within the past 14 days * No fine needle aspirations other than in the breast within the past 7 days * No placement of a vascular access device within the past 7 days * No major surgical procedure within the past 4 weeks * No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) and recovered * No radiotherapy within the past 4 weeks * No previous treatment with bevacizumab * No need for major surgical procedure during the course of the study * No other cancer immunotherapy or biologic therapy while on the study * No concurrent or recent (within past 10 days) use of full-dose oral or parenteral anticoagulants (heparin \> 10,000/day or an INR \> 1.5) or thrombolytic agents * 1 mg of warfarin is permitted as required to maintain patency of preexisting, permanent indwelling IV catheters * No chronic, daily treatment with aspirin (\> 325 mg/day) or nonsteroidal anti-inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases)

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

Sponsors & Collaborators

• Herbert Hurwitz, MD: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Herbert I. Hurwitz, MD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: January 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: July 7, 2016

Record last verified: 2016-07