Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00217425
First received: September 20, 2005
Last updated: April 22, 2009
Last verified: March 2009
  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 help 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 bevacizumab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with several chemotherapy drugs (combination chemotherapy) works in treating patients with peripheral T-cell lymphoma or natural killer cell neoplasms.


Condition Intervention Phase
Lymphoma
Biological: bevacizumab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 1 year progression-free survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (complete remission [(CR), unconfirmed CR, or functional CR] and partial remission) after courses 3, 6, and 8 [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: July 2006
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 12-month progression-free survival of patients with peripheral T-cell or natural killer cell neoplasms treated with bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).

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 achieving stable disease (SD) after course 3 and remain in SD after course 6 should discontinue treatment. Patients achieving PR after course 3 who then achieve CR, CRu, or functional CR after course 6 and patients achieving SD after course 3 who then achieve PR after course 6 receive 2 additional courses of bevacizumab, cyclophosphamide, doxorubicin, and vincristine in courses 7 and 8. Patients achieving a complete remission (CR) or unconfirmed CR (CRu) after 6 courses or after 8 courses or patients achieving partial response (PR) after 8 courses, then receive bevacizumab alone IV 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 2 years, and then every 6 months for up to 5 years.

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

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of peripheral T-cell or natural killer cell neoplasm

    • Any stage disease allowed
    • HTLV-positive tumors allowed
  • At least 1 objective measurable disease parameter

    • Abnormal positron emission tomography scans are not considered evidence of measurable disease unless results are confirmed by CT scan or other appropriate imaging techniques
  • No anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma

    • ALK-negative T-cell large cell lymphoma allowed
  • No cutaneous T-cell lymphoma
  • No history of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/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 within the past 6 months
  • 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 other clinically significant cardiovascular or peripheral vascular disease
  • History of deep venous thrombosis allowed provided patient is on a stable dose of anticoagulants for at least 2 weeks prior to study entry
  • LVEF ≥ 50%

Pulmonary

  • History of pulmonary embolism allowed provided patient is on a stable dose of anticoagulants for at least 2 weeks prior to study entry

Gastrointestinal

  • No abdominal fistula within the past 6 months
  • No gastrointestinal perforation within the past 6 months
  • No intra-abdominal abscess within the past 6 months

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
  • No other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • One prior cycle of CHOP for PTCL allowed

Endocrine therapy

  • Not specified

Surgery

  • More than 4 weeks since prior major invasive surgery or open biopsy
  • At least 7 days since prior minor surgery

    • Peripheral lymph node core biopsy, bone marrow biopsy, fine needle aspiration, skin biopsy, or central line placement are not considered minor surgical procedures
  • No concurrent major surgery

Other

  • More than 7 days since prior and no concurrent anti-platelet drugs (e.g., ticlopidine, clopidogrel, or cilostazol) except aspirin or other nonsteroidal anti-inflammatory drugs
  • Concurrent anticoagulants allowed provided patient is on a stable dose

    • INR must be stable for at least 2 weeks prior to study entry
    • PT/INR and/or PTT must be closely monitored and levels kept within acceptable range for underlying thrombotic disease
    • Concurrent heparin flush for maintenance of central line patency allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217425

  Show 110 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Kristen N. Ganjoo, MD Veterans Affairs Medical Center - Palo Alto
Investigator: Ranjana Advani, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT00217425     History of Changes
Other Study ID Numbers: CDR0000441194, ECOG-E2404
Study First Received: September 20, 2005
Last Updated: April 22, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
peripheral T-cell lymphoma

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Bevacizumab
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 21, 2014