Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Relapsed Follicular Lymphoma |
Intervention | Drug: rituximab Drug: cyclophosphamide Drug: doxorubicin Drug: VELCADE Drug: prednisone |
Phase | Phase 2 |
Sponsor | Millennium Pharmaceuticals, Inc. |
Responsible Party | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier | NCT00715208 |
First Received | July 11, 2008 |
Last Updated | April 26, 2013 |
Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | July 11, 2008 |
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Last Updated Date | April 26, 2013 |
Start Date | September 2008 |
Estimated Primary Completion Date | March 2011 |
Current Primary Outcome Measures | Number of Patients With Complete Response (CR) [Time Frame: 30 weeks] [Designated as safety issue: No]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. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma |
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Official Title | A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma. |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Relapsed Follicular Lymphoma |
Intervention | Drug: rituximab Drug: cyclophosphamide Drug: doxorubicin Drug: VELCADE Drug: prednisone |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 55 |
Estimated Completion Date | March 2011 |
Estimated Primary Completion Date | February 2011 |
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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Puerto Rico |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00715208 |
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Other Study ID Numbers | C05012 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Millennium Pharmaceuticals, Inc. |
Study Sponsor | Millennium Pharmaceuticals, Inc. |
Collaborators | Not Provided |
Investigators | Study Director: Medical Monitor Millennium Pharmaceuticals, Inc. |
Verification Date | April 2013 |
Locations[ + expand ][ + ]
Northwest Alabama Center, PC | Muscle Shoals, Alabama, United States, 35661 |
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Providence Saint Joseph Medical Center | Burbank, California, United States, 91505 |
Pacific Coast Hematology Oncology Medical Group | Fountain Valley, California, United States, 92708 |
Loma Linda U Cancer Center | Loma Linda, California, United States, 92354 |
Desert Hematology Medical Group, Inc. | Rancho Mirage, California, United States, 92270 |
Cancer Center of Central Connecticut | Southington, Connecticut, United States, 06498 |
Ocala Cancer Institute | Ocala, Florida, United States, 34471 |
Northwest Georgia Oncology Centers, PC | Marietta, Georgia, United States, 30060 |
Southern Illinois Hematology Oncology | Centralia, Illinois, United States, 62801 |
Alexian Brothers Hospital Network | Elk Grove Village, Illinois, United States, 60007 |
Clintell, Inc. | Skokie, Illinois, United States, 60077 |
Cancer Care Center, Inc. | New Albany, Indiana, United States, 47150 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa, United States, 51101 |
Hutchinson Clinic | Hutchinson, Kansas, United States, 67502 |
Purchase Cancer Group | Paducah, Kentucky, United States, 42001 |
Medical Oncology, LLC | Baton Rouge, Louisiana, United States, 70809 |
St. Joseph Mercy Hospital | Ann Arbor, Michigan, United States, 48106 |
Kalamazoo Hematology and Oncology | Kalamazoo, Michigan, United States, 49048 |
Jackson Oncology Associates, PLLC | Jackson, Mississippi, United States, 39202 |
St. Louis Cancer Care, LLP | Chesterfield, Missouri, United States, 63017 |
Nebraska Hematology-Oncology, PC | Lincoln, Nebraska, United States, 68506 |
Great Plains Regional Medical Center | North Platte, Nebraska, United States, 69101 |
Southern Nevada Cancer Research Foundation | Las Vegas, Nevada, United States, 89106 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, United States, 03756 |
San Juan Oncology Associates | Farmington, New Mexico, United States, 87401 |
NYU Clinical Cancer Center | New York, New York, United States, 10016 |
Interlakes Foundation | Rochester, New York, United States, 14623 |
New York Medical College | Valhalla, New York, United States, 10595 |
Gabrail Cancer Center | Canton, Ohio, United States, 44718 |
Oklahoma Oncology and Hematology, PC | Oklahoma City, Oklahoma, United States, 73112 |
Oklahoma Oncology and Hematology, PC | Tulsa, Oklahoma, United States, 74136 |
Temple University | Philadelphia, Pennsylvania, United States, 19140 |
Western Pennsylvania Cancer Institute | Pittsburgh, Pennsylvania, United States, 15224 |
Allegheny-Singer Research Institute | Pittsburgh, Pennsylvania, United States, 15212 |
Landmark Medical Center | Woonsocket, Rhode Island, United States, 02895 |
Avera Cancer Institute | Sioux Falls, South Dakota, United States, 57105 |
University of Tennessee Medical Center | Knoxville, Tennessee, United States, 37920 |
HOPE Oncology | Richardson, Texas, United States, 75080 |
Northern Utah Associates | Ogden, Utah, United States, 84403 |
Marshall University | Huntington, West Virginia, United States, 25701 |
West Virginia University Health Science Center | Morgantown, West Virginia, United States, 26505 |
Marshfield Clinic | Marshfield, Wisconsin, United States, 54449 |
Auxilio Cancer Center | Hato Rey, Puerto Rico, 00919 |