Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma

NCT ID: NCT00715208

Last Updated: 2013-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-03-31

Brief Summary

This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.

Conditions

Relapsed Follicular Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VELCADE R-CAP

VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.

Group Type: EXPERIMENTAL

rituximab

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

doxorubicin

Intervention Type: DRUG

VELCADE

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

VELCADE R-CP

VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 intravenous on Day 1, cyclophosphamide 1000 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.

Group Type: EXPERIMENTAL

rituximab

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

VELCADE

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Interventions

rituximab

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

doxorubicin

Intervention Type: DRUG

VELCADE

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patient 18 years of age or older
• Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma. Patients with transformed follicular lymphoma are eligible, provided there has previously been pathologic documentation of follicular lymphoma.
• Documented relapse or progression following prior antineoplastic therapy
• At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and greater than 1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
• No clinically significant evidence of active central nervous system lymphoma
• Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group Oncology Group [ECOG] status ≤2)

Exclusion Criteria

• Diagnosed or treated for a malignancy other than Non-Hodgkin's Lymphoma (NHL) within 2 years of first dose, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Patients with prostate cancer who were treated with definitive radiotherapy who have a serum prostate-specific antigen <1 ng/mL are not excluded. Patients are not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
• Received any of the following treatments or procedures outside of the specified timeframes:

• Prior treatment with VELCADE
• Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2, if assigned to Arm A (VELCADE-R-CAP)
• Antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1 of Cycle 1
• Nitrosoureas within 6 weeks before Day 1 of Cycle 1
• Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1
• Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time
• Major surgery within 2 weeks before Day 1 of Cycle 1

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Northwest Alabama Center, PC

Muscle Shoals, Alabama, United States

Providence Saint Joseph Medical Center

Burbank, California, United States

Pacific Coast Hematology Oncology Medical Group

Fountain Valley, California, United States

Loma Linda U Cancer Center

Loma Linda, California, United States

Desert Hematology Medical Group, Inc.

Rancho Mirage, California, United States

Cancer Center of Central Connecticut

Southington, Connecticut, United States

Ocala Cancer Institute

Ocala, Florida, United States

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States

Southern Illinois Hematology Oncology

Centralia, Illinois, United States

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, United States

Clintell, Inc.

Skokie, Illinois, United States

Cancer Care Center, Inc.

New Albany, Indiana, United States

Siouxland Hematology Oncology Associates

Sioux City, Iowa, United States

Hutchinson Clinic

Hutchinson, Kansas, United States

Purchase Cancer Group

Paducah, Kentucky, United States

Medical Oncology, LLC

Baton Rouge, Louisiana, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Kalamazoo Hematology and Oncology

Kalamazoo, Michigan, United States

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

St. Louis Cancer Care, LLP

Chesterfield, Missouri, United States

Nebraska Hematology-Oncology, PC

Lincoln, Nebraska, United States

Great Plains Regional Medical Center

North Platte, Nebraska, United States

Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

NYU Clinical Cancer Center

New York, New York, United States

Interlakes Foundation

Rochester, New York, United States

New York Medical College

Valhalla, New York, United States

Gabrail Cancer Center

Canton, Ohio, United States

Oklahoma Oncology and Hematology, PC

Oklahoma City, Oklahoma, United States

Oklahoma Oncology and Hematology, PC

Tulsa, Oklahoma, United States

Temple University

Philadelphia, Pennsylvania, United States

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, United States

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, United States

Landmark Medical Center

Woonsocket, Rhode Island, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

HOPE Oncology

Richardson, Texas, United States

Northern Utah Associates

Ogden, Utah, United States

Marshall University

Huntington, West Virginia, United States

West Virginia University Health Science Center

Morgantown, West Virginia, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Auxilio Cancer Center

Hato Rey, , Puerto Rico

Countries

United States; Puerto Rico

References

Craig M, Hanna WT, Cabanillas F, Chen CS, Esseltine DL, Neuwirth R, O'Connor OA. Phase II study of bortezomib in combination with rituximab, cyclophosphamide and prednisone with or without doxorubicin followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma. Br J Haematol. 2014 Sep;166(6):920-8. doi: 10.1111/bjh.12991. Epub 2014 Jul 9.

Reference Type: DERIVED

PMID: 25039282 (View on PubMed)

Other Identifiers

C05012

Identifier Type: -

Identifier Source: org_study_id