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Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00006473   Information provided by National Cancer Institute (NCI)
First Received: November 6, 2000   Last Updated: July 23, 2008   History of Changes

November 6, 2000
July 23, 2008
September 2000
 
 
 
Complete list of historical versions of study NCT00006473 on ClinicalTrials.gov Archive Site
 
 
 
Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma.
  • Determine the treatment-related toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive).

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 2-3 years.

Phase II
Interventional
Treatment
Lymphoma
Drug: oxaliplatin
 
Oki Y, McLaughlin P, Pro B, Hagemeister FB, Bleyer A, Loyer E, Younes A. Phase II study of oxaliplatin in patients with recurrent or refractory non-Hodgkin lymphoma. Cancer. 2005 Aug 15;104(4):781-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype

    • Indolent

      • Follicular small cleaved cell
      • Follicular mixed cell
      • Small lymphocytic
      • Mucosa-associated lymphoid tissue (MALT)
      • Monocytoid B-cell
      • Waldenstrom's macroglobulinemia
    • Aggressive

      • Follicular large cell
      • Diffuse large cell
      • Immunoblastic
      • Mantle cell
      • Ki-1+ NHL
      • Peripheral T-cell
      • Angiocentric and angioimmunoblastic
      • Transformed lymphoma
  • Bidimensionally measurable disease
  • No more than 3 prior treatment regimens as follows:

    • Primary radiotherapy is 1 regimen
    • Combined therapy with radiotherapy and chemotherapy is 1 regimen
    • Alternating therapy is 1 regimen
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2
  • Karnofsky 50-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC count at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • SGOT/SGPT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • No neuropathy greater than grade 1
  • No history of allergy to platinum compounds or antiemetics
  • No uncontrolled illness
  • No active infection
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent colony-stimulating factors during first course of therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Other:

  • No other concurrent investigational drugs
  • No concurrent antiretroviral therapy for HIV-positive patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006473
 
CDR0000068297, MDA-ID-99406, NCI-1652
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Anas Younes, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP