Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma - Full Text View

Sponsor:	University of Washington
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072514

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Biological: rituximab Drug: carboplatin Drug: dexamethasone Drug: gemcitabine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Dexamethasone Carboplatin Dexamethasone acetate Doxiproct plus Gemcitabine Gemcitabine hydrochloride Rituximab Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate after 2-4 courses [ Designated as safety issue: No ]

Estimated Enrollment:	51
Study Start Date:	December 2001
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stratum I (CD20 negative): 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.	Drug: carboplatin Given IV Drug: dexamethasone Given orally Drug: gemcitabine hydrochloride Given IV
Stratum II (CD20 positive): Experimental Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8.	Biological: rituximab Given IV Drug: carboplatin Given IV Drug: dexamethasone Given orally Drug: gemcitabine hydrochloride Given IV

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072514

Locations

United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023

Sponsors and Collaborators

University of Washington

National Cancer Institute (NCI)

Investigators

Study Chair:	Ajay K. Gopal, MD	Seattle Cancer Care Alliance
Investigator:	John Pagel, MD, PhD	Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Seattle Cancer Care Alliance ( Ajay K. Gopal )
Study ID Numbers:	CDR0000339814, UW-LYM.03.01, PSOC-2003, LILLY-B9E-US-X348
Study First Received:	November 4, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00072514 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma

recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
anaplastic large cell lymphoma
intraocular lymphoma
recurrent mycosis fungoides/Sezary syndrome
angioimmunoblastic T-cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Gemcitabine
Lymphoma

Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Rituximab
Gastrointestinal Agents
Enzyme Inhibitors
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Glucocorticoids
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009