Clinical Trial: Bevacizumab and Combination Chemotherapy in Patients With Hematologic Cancers

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) September 2005

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217425

Purpose

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving monoclonal antibodies together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients with hematologic cancers.

Condition Intervention Phase
anaplastic large cell lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
 Drug: bevacizumab
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: prednisone
 Drug: vincristine
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: growth factor antagonist therapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bevacizumab and Combination Chemotherapy Comprising Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms

Further Study Details: 

OBJECTIVES:

Primary

Secondary

  • Determine the overall response rate (complete remission [(CR), unconfirmed CR, or functional CR] and partial remission) in these patients after courses 3, 6, and 8 of this treatment regimen.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, cyclophosphamide IV over 15 minutes, doxorubicin IV and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or who achieve partial remission (PR) after 6 courses receive 2 additional courses of bevacizumab and chemotherapy. Patients achieving a complete remission (CR), functional CR, or unconfirmed CR after 6 courses or after 8 courses or patients achieving PR after 8 courses, then receive bevacizumab alone over 30 minutes on day 1. Treatment with bevacizumab alone repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 22 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3(500/mm^3 if due to bone marrow involvement with lymphoma)
  • Platelet count ≥ 100,000/mm^3(50,000/mm^3 if due to bone marrow involvement with lymphoma)
  • No evidence of bleeding diathesis or coagulopathy

Hepatic

  • Bilirubin ≤ 2.0 mg/dL (≤ 3 times upper limit of normal [ULN] if due to hepatic involvement with lymphoma)
  • AST ≤ 2 times ULN (5 times ULN if due to hepatic involvement with lymphoma)
  • PT, INR, and PTT ≤ 1.5 times normal

Renal

  • Creatinine ≤ 2.0 mg/dL
  • Urinary protein:creatinine ratio < 1

Cardiovascular

  • No cerebrovascular accident within the past 6 months
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No New York Heart Association class II-IV congestive heart failure
  • No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg)
  • No stroke within the past 6 months
  • No other clinically significant cardiovascular or peripheral vascular disease
  • Patients with a history of deep venous thrombosis allowed provided they are on a stable dose of anticoagulants for at least 2 weeks prior to study entry
  • LVEF ≥ 50%

Pulmonary

  • Patients with a history of pulmonary embolism allowed provided they are on a stable dose of anticoagulants for at least 2 weeks prior to study entry

Gastrointestinal

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of active seizures
  • No significant traumatic injury within the past 4 weeks
  • No non-healing ulcer (unless involved with lymphoma)
  • No bone fracture
  • No active infection requiring parenteral antibiotics
  • No known HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior or other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior or concurrent radiotherapy

Surgery

  • More than 4 weeks since prior major invasive surgery or open biopsy
  • At least 7 days since prior minor surgery (e.g., peripheral lymph node core biopsy, bone marrow biopsy, fine needle aspiration, skin biopsy, or central line placement)
  • No concurrent major surgery

Other

  • More than 7 days since prior and no concurrent anti-platelet drugs (e.g., ticlopidine or clopidogrel) except aspirin or other nonsteroidal anti-inflammatory drugs
  • More than 7 days since prior and no concurrent prophylactic heparin for deep vein thrombosis
  • Concurrent heparin flush for maintenance of central line patency allowed
  • Concurrent anticoagulants allowed provided patient is on a stable dose and INR is stable for at least 2 weeks prior to study entry

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00217425


Study chairs or principal investigators

Kristen N. Ganjoo, MD,  Study Chair,  Veterans Affairs Medical Center - Palo Alto   
Ranjana Advani, MD,  Stanford University   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000441194; ECOG-E2404
Last Updated:  September 21, 2005
Record first received:  September 20, 2005
ClinicalTrials.gov Identifier:  NCT00217425
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27

Resources




Common Treatments

[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Follow Us