Trials / Completed
CompletedNCT01538641
Phase II Evaluation of Gemcitabine- Rituximab-Oxaliplatin Combination (GROC) in Relapsed Aggressive Lymphomas
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Auxilio Mutuo Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2003-10-01
- Primary completion
- 2007-08-01
- Completion
- 2008-12-01
- First posted
- 2012-02-24
- Last updated
- 2012-07-13
Source: ClinicalTrials.gov record NCT01538641. Inclusion in this directory is not an endorsement.