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Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00072514   Information provided by National Cancer Institute (NCI)
First Received: November 4, 2003   Last Updated: February 6, 2009   History of Changes

November 4, 2003
February 6, 2009
December 2001
April 2013   (final data collection date for primary outcome measure)
Response rate after 2-4 courses [ Designated as safety issue: No ]
Response rate after 2-4 courses
Complete list of historical versions of study NCT00072514 on ClinicalTrials.gov Archive Site
 
 
 
Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma
A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, carboplatin, and dexamethasone with or without rituximab in treating patients who have relapsed or primary refractory lymphoma.

OBJECTIVES:

  • Determine the feasibility and safety of gemcitabine, carboplatin, and dexamethasone with or without rituximab, in terms of response rate, in patients with relapsed or primary refractory lymphoid malignancy.
  • Determine the efficacy of these regimens in these patients.
  • Determine the impact of these regimens on stem cell reserve in these patients.
  • Determine the remission duration in patients treated with these regimens.

OUTLINE: This is a pilot study. Patients are stratified according to CD20 expression (negative vs positive).

  • Stratum I (CD20 negative): Patients receive carboplatin IV over 30 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; and oral dexamethasone on days 1-4.
  • Stratum II (CD20 positive): Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8.

In both strata, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study within 2-3 years.

Phase II
Interventional
Treatment
Lymphoma
  • Biological: rituximab
  • Drug: carboplatin
  • Drug: dexamethasone
  • Drug: gemcitabine hydrochloride
  • Experimental: Patients receive carboplatin IV over 30 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; and oral dexamethasone on days 1-4.
  • Experimental: Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
51
 
April 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of relapsed or primary refractory lymphoid malignancy, with REAL or WHO classification provided, including the following types:

    • B-cell lymphoma
    • T-cell lymphoma
    • Hodgkin's lymphoma
  • No disease refractory (i.e., not responded or progressed within 6 months) to a carboplatin- or cisplatin-based regimen or a gemcitabine-based regimen
  • Bidimensionally measurable disease by CT chest/abdomen/pelvis within 28 days of enrollment

    • At least 1 cm by CT scan, MRI, medical photograph (skin or oral lesion), plain x-ray, or other conventional techniques OR at least 2 cm by palpation
  • Bone marrow aspirate and biopsy within the past 28 days

    • No prior anticancer therapy during the interval between bone marrow aspirate and biopsy and study entry
  • No active CNS lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • SWOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Patients with cytopenia due to disease in bone marrow that do not meet these criteria may be enrolled at the Study Chair's discretion

Hepatic

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • No active HBV infection or hepatitis

Renal

  • Creatinine less than 1.5 times ULN
  • Creatine clearance greater than 50 mL/min

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other medical condition that would preclude study treatment
  • Must be anticipated to complete at least 2 courses of therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00072514
Ajay K. Gopal, Seattle Cancer Care Alliance
CDR0000339814, UW-LYM.03.01, PSOC-2003, LILLY-B9E-US-X348
University of Washington
National Cancer Institute (NCI)
Study Chair: Ajay K. Gopal, MD Seattle Cancer Care Alliance
Investigator: John Pagel, MD, PhD Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
November 2008

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