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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 CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
St. Rita's Medical CenterLima, Ohio  45801
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Southwest Medical CenterLiberal, Kansas  67901
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Hematology and Oncology AssociatesChicago, Illinois  60611
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
La Grange Oncology Associates - GenevaNaperville, Illinois  60563
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Central Pennsylvania Hematology and Medical Oncology Associates, PCLemoyne, Pennsylvania  17043
Galesburg Clinic, PCGalesburg, Illinois  61401
California Cancer Care, Incorporated - GreenbraeGreenbrae, California  94904
Doylestown Hospital Cancer CenterDoylestown, Pennsylvania  18901