Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms
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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 |
- 1 year progression-free survival rate [ Designated as safety issue: No ]
- 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) |
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 |
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
Show 110 Study Locations| 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 June 18, 2013