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Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1 year progression-free survival rate

Safety Issue:

No

Principal Investigator

Kristen N. Ganjoo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - Palo Alto

Authority:

United States: Federal Government

Study ID:

CDR0000441194

NCT ID:

NCT00217425

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Neoplasms
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
St. Rita's Medical Center Lima, Ohio  45801
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Methodist Medical Center of Illinois Peoria, Illinois  61636
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Dickinson County Healthcare System Iron Mountain, Michigan  49801
Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
Lewistown Hospital Lewistown, Pennsylvania  17044
Mount Nittany Medical Center State College, Pennsylvania  16803
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Southwest Medical Center Liberal, Kansas  67901
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Front Range Cancer Specialists Fort Collins, Colorado  80528
Hematology Oncology Associates - Skokie Skokie, Illinois  60076
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Hematology and Oncology Associates Chicago, Illinois  60611
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Midwest Center for Hematology/Oncology Joliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
La Grange Oncology Associates - Geneva Naperville, Illinois  60563
Cancer Care and Hematology Specialists of Chicagoland - Niles Niles, Illinois  60714
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Greater Baltimore Medical Center Cancer Center Baltimore, Maryland  21204
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Central Pennsylvania Hematology and Medical Oncology Associates, PC Lemoyne, Pennsylvania  17043
Galesburg Clinic, PC Galesburg, Illinois  61401
California Cancer Care, Incorporated - Greenbrae Greenbrae, California  94904
Doylestown Hospital Cancer Center Doylestown, Pennsylvania  18901