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

July 11, 2012 updated by: Fernando Cabanillas, Auxilio Mutuo Cancer Center

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The response rate of the combination of Gemcitabine-Oxaliplatin-Rituximab.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auxilio Mutuo Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (Estimate)

February 24, 2012

Study Record Updates

Last Update Posted (Estimate)

July 13, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCAM-03-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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