ABT-510 and Bevacizumab in Treating Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Herbert Hurwitz, Duke University
ClinicalTrials.gov Identifier:
NCT00276562
First received: January 12, 2006
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

RATIONALE: ABT-510 and bevacizumab may stop the growth of solid tumors by blocking blood flow to the tumor. 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. Giving ABT-510 together with bevacizumab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of ABT-510 and bevacizumab in treating patients with advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: bevacizumab
Drug: ABT-510
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of ABT-510 in Combination With Bevacizumab in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 38
Study Start Date: May 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the recommended phase II dose for the combination of ABT-510 plus bevacizumab in patients with advanced solid tumors.
  • Evaluate dose-limiting toxicities and non dose-limiting toxicities of this combination.

Secondary

  • Collect preliminary data on the clinical activity of this combination (tumor response rate, progression-free survival, and rate of stable disease > 6 months).

OUTLINE: This is a dose-escalation study. Patients are sequentially enrolled with the first 9-18 patients assigned to part 1 and the next 20 patients assigned to part 2 of the study.

  • Part 1: Patients receive ABT-510 subcutaneously (SC) twice daily on days 1-28 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of patients receive escalating doses of ABT-510 and bevacizumab until the recommended phase II dose is determined. Patients in part 2 are treated at the recommenced phase II dose.

  • Part 2: The first 10 patients are assigned to group 1. The next 10 patients are assigned to group 2.

    • Group 1: Patients receive ABT-510 SC twice daily beginning on day 1 and bevacizumab IV once every 14 days beginning on day 15.
    • Group 2: Patients receive ABT-510 SC twice daily beginning on day 15 and bevacizumab IV once every 14 days beginning on day 1.

In both groups, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced solid tumor
  • Refractory to standard therapy or for which there is no standard therapy
  • No known brain metastases

    • Patients with primary malignancies known to metastasize to the brain (such as lung cancer, breast cancer, renal cell cancer, sarcoma, carcinoma of unknown primary, melanoma, or head and neck cancers) or patients with symptoms of brain metastases should have a brain MRI within 28 days of enrollment to confirm the absence of CNS metastases

      • Contrast CT scan is acceptable for patients who are unable to undergo a brain MRI
  • No squamous cell carcinoma of the lung

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • PT/INR/PTT ≤ 1.2 times ULN
  • AST/ALT ≤ 2.5 times ULN (5 times ULN if known hepatic metastases)
  • Urine protein:creatinine ≤ 1.0 (spot urine sample)
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during the study and for up to 4 months after study completion
  • No New York Heart Association class III or IV heart disease
  • No angina requiring nitrates
  • No myocardial infarction in the past 6 months
  • No cerebrovascular accident or transient ischemic attack in the past 6 months
  • No thrombosis within 3 months
  • No poorly controlled hypertension (i.e., blood pressure > 160/100 mm Hg)
  • No ventricular arrhythmia requiring medication
  • No poorly controlled or clinically significant atherosclerotic vascular disease
  • No coagulopathy
  • No presence of bleeding diathesis
  • No non-healing wounds
  • No gastrointestinal (GI) perforation within past 6 months
  • No acute GI bleed requiring transfusion or invasive intervention within the past 6 months
  • No hemoptysis greater than 1 tablespoon within 6 months
  • No other major bleeding event
  • No history of intra-abdominal fistula or abscess within the past 6 months
  • No uncontrolled intercurrent illness
  • No history of intolerance to bevacizumab or ABT-510
  • No ongoing or active infection
  • No psychiatric illness or social situations that would limit safety or compliance with study requirements
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study participation

PRIOR CONCURRENT THERAPY:

  • No angioplasty in the past 6 months
  • No cardiac or vascular stenting in the past 6 months
  • Patients with prostate cancer who are already receiving androgen deprivation therapy (i.e., leuprolide or goserelin) for longer than 3 months may continue on this therapy during the study
  • No major surgery within past 28 days
  • No other investigational agents within the past 28 days
  • No chemotherapy for cancer within past 21 days
  • No biologic therapy for cancer within past 21 days
  • No radiation therapy within past 21 days
  • No hormonal therapy within past 21 days
  • No minor surgical procedures within past 14 days
  • Initiation or adjustment of blood pressure (BP) medication is permitted prior to study entry

    • Must have 3 consecutive BP readings less than 150/90 mm Hg

      • Each reading must be separated by a minimum of 24 hours
  • No concurrent use of therapeutic anticoagulation

    • Prophylactic low-dose anticoagulation for indwelling catheter is permitted provided PT/PTT is within normal limits
  • No use of antiplatelet agents other than aspirin (< 325 mg/day) or standard dose nonsteroidal anti-inflammatory drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276562

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Herbert I. Hurwitz, MD Duke Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Herbert Hurwitz, MD, Duke University
ClinicalTrials.gov Identifier: NCT00276562     History of Changes
Other Study ID Numbers: CDR0000449951, DUMC-6074-05-7R1ER, DUMC-6074
Study First Received: January 12, 2006
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014