Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma - Full Text View

Sponsor:	Millennium Pharmaceuticals, Inc.
Information provided by:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00715208

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.

Condition	Intervention	Phase
Relapsed Follicular Lymphoma	Drug: VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin Drug: VELCADE, rituximab, cyclophosphamide, and prednisone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
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.

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Cyclophosphamide Prednisone Doxorubicin Doxorubicin hydrochloride Rituximab Bortezomib

U.S. FDA Resources

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:

Complete response rate [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety of the drug combinations [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	88
Study Start Date:	September 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin	Drug: VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin 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 PO on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.
2: Experimental VELCADE, rituximab, cyclophosphamide, and prednisone	Drug: VELCADE, rituximab, cyclophosphamide, and prednisone 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 by mouth on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.

Arms

Assigned Interventions

1: Experimental

VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin

Drug: VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin

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 PO on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.

2: Experimental

VELCADE, rituximab, cyclophosphamide, and prednisone

Drug: VELCADE, rituximab, cyclophosphamide, and prednisone

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 by mouth on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715208

Contacts

Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center

1-866-835-2233

medical@mlnm.com

Show 43 Study Locations

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Study Director:

Medical Monitor

Millennium Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Millennium Pharmaceuticals, Inc. ( Clinical Research Monitor )
Study ID Numbers:	C05012
Study First Received:	July 11, 2008
Last Updated:	December 3, 2009
ClinicalTrials.gov Identifier:	NCT00715208 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Lymphoma, Follicular
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Lymphoma
Alkylating Agents
Immunoproliferative Disorders

Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Bortezomib
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on February 08, 2010