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

NCT00715208 | Completed Phase 2 Results

• 1 other identifier: C05012
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 43

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Complete Response (CR)

  Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.

  30 weeks

Secondary Outcomes (4)

• Number of Participants With Overall Response (OR)

  30 weeks

• Percentage of Participants With Progression-free Survival (PFS) at 1 Year

  Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD

• Duration of Response

  2 years

• Number of Patients Who Experienced at Least One Serious Adverse Event

  From completion of informed consent through 30 days after the last dose of study drug

Study Arms (2)

VELCADE R-CAP

EXPERIMENTAL

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.

Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: VELCADE; Drug: prednisone

VELCADE R-CP

EXPERIMENTAL

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.

Drug: rituximab; Drug: cyclophosphamide; Drug: VELCADE; Drug: prednisone

Interventions

rituximab DRUG

VELCADE R-CAP; VELCADE R-CP

cyclophosphamide DRUG

VELCADE R-CAP; VELCADE R-CP

doxorubicin DRUG

VELCADE R-CAP

VELCADE DRUG

VELCADE R-CAP; VELCADE R-CP

prednisone DRUG

VELCADE R-CAP; VELCADE R-CP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (43)

Northwest Alabama Center, PC

Muscle Shoals, Alabama, 35661, United States

Location

Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

Pacific Coast Hematology Oncology Medical Group

Fountain Valley, California, 92708, United States

Location

Loma Linda U Cancer Center

Loma Linda, California, 92354, United States

Location

Desert Hematology Medical Group, Inc.

Rancho Mirage, California, 92270, United States

Location

Cancer Center of Central Connecticut

Southington, Connecticut, 06498, United States

Location

Ocala Cancer Institute

Ocala, Florida, 34471, United States

Location

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, 30060, United States

Location

Southern Illinois Hematology Oncology

Centralia, Illinois, 62801, United States

Location

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, 60007, United States

Location

Clintell, Inc.

Skokie, Illinois, 60077, United States

Location

Cancer Care Center, Inc.

New Albany, Indiana, 47150, United States

Location

Siouxland Hematology Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Hutchinson Clinic

Hutchinson, Kansas, 67502, United States

Location

Purchase Cancer Group

Paducah, Kentucky, 42001, United States

Location

Medical Oncology, LLC

Baton Rouge, Louisiana, 70809, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Kalamazoo Hematology and Oncology

Kalamazoo, Michigan, 49048, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

St. Louis Cancer Care, LLP

Chesterfield, Missouri, 63017, United States

Location

Nebraska Hematology-Oncology, PC

Lincoln, Nebraska, 68506, United States

Location

Great Plains Regional Medical Center

North Platte, Nebraska, 69101, United States

Location

Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

Interlakes Foundation

Rochester, New York, 14623, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Oklahoma Oncology and Hematology, PC

Oklahoma City, Oklahoma, 73112, United States

Location

Oklahoma Oncology and Hematology, PC

Tulsa, Oklahoma, 74136, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, 15224, United States

Location

Landmark Medical Center

Woonsocket, Rhode Island, 02895, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

HOPE Oncology

Richardson, Texas, 75080, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Marshall University

Huntington, West Virginia, 25701, United States

Location

West Virginia University Health Science Center

Morgantown, West Virginia, 26505, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Auxilio Cancer Center

Hato Rey, 00919, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 25039282 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Bortezomib; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Carol Ann Satler, MD, PhD
• Organization: Millennium Pharmaceuticals

carol.satler@mpi.com

617- 551-3729

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 29, 2013
• Results First Posted: April 29, 2013

Record last verified: 2013-04

Locations

US (42); PR (1)