Phase II Evaluation of Gemcitabine- Rituximab-Oxaliplatin Combination (GROC) in Relapsed Aggressive Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01538641
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
Fernando Cabanillas, Auxilio Mutuo Cancer Center

Brief Summary:

Study Proposal:

Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol, Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more attractive and should be explored in this group of disorders. Based on these data and considering the advantage of its favorable toxicity profile, we propose a phase II study in patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including peripheral T-cell lymphomas which are known to have a poor outcome when compared with equivalent aggressive B-cell lymphomas.

Condition or disease Intervention/treatment Phase
Refractory Aggressive Non-Hodgkin's Lymphoma Relapsing Aggressive Non-Hodgkin's Lymphoma Drug: Rituximab, Gemcitabine, Oxaliplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation Of GROC (Gemcitabine- Rituximab-Oxaliplatin Combination) Given Every 14 Days For The Treatment Of Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
Study Start Date : October 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Rituximab, Gemcitabine, Oxaliplatin
Rituximab:375 mg/m2; on day 1 of each 14 days cycle. Gemcitabine:1,000 mg/m2 on day 2 of each 14 days cycle. Oxaliplatin:100 mg/m2; on day 2 of each 14 days cycle. Total number of cycles: 6 cycles.

Primary Outcome Measures :
  1. The response rate of the combination of Gemcitabine-Oxaliplatin-Rituximab. [ Time Frame: 5 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with refractory or relapsed aggressive non-Hodgkin's Lymphoma. The definition of refractory includes patients who either did not respond to prior therapy or those whose best response was a PR after at least 4 courses of chemotherapy. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
  • Histologic or cytological confirmation of refractory or relapsed aggressive non-Hodgkin's Lymphoma is desirable but not mandatory and will be left to the discretion of the investigator.
  • Must have measurable or evaluable disease.
  • No more than 4 previous regimens of chemotherapy will be allowed, including stem cell or bone marrow transplant.
  • Patients must be more than 18 years old.
  • No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
  • Written Consent
  • Those patients who have previously received a platinum or nucleoside analogue-containing regimen are eligible.
  • Patients who are candidates for stem cell or marrow transplant will be included

Exclusion Criteria:

  • Patients with a previous or concurrent history of cancer with the exception of: 1-treated carcinoma in situ of cervix or breast. 2- treated squamous or basal cell skin cancer, or 3- any other surgically cured malignancy from which the patient has been disease free for at least 5 years.
  • HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
  • Patients with severe neuropathy will be excluded.
  • Chemotherapy or Radiotherapy within the previous 3 weeks prior to entering study.

Responsible Party: Fernando Cabanillas, Hematology - Oncologist, Auxilio Mutuo Cancer Center Identifier: NCT01538641     History of Changes
Other Study ID Numbers: CCAM-03-01
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents