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Phase II Pilot Study of Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Patients With Relapsed or Primary Refractory Lymphoid Malignancy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry UW-LYM.03.01
PSOC-2003, LILLY-B9E-US-X348, NCT00072514

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Patient Characteristics:

Age

18 and over

Performance status

SWOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm³
Platelet count at least 100,000/mm³
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

Expected Enrollment

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

Outcomes

Primary Outcome(s)

Response rate after 2-4 courses

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.

Trial Contact Information

Trial Lead Organizations

University of Washington School of Medicine

Ajay Gopal, MD, Protocol chair
Ph: 206-288-2035
John Pagel, MD, PhD, Protocol co-chair
Ph: 206-667-1868

Registry Information

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

Trial Start Date		2001-12-14

Trial Completion Date		2013-04-30 (estimated)

Registered in ClinicalTrials.gov		NCT00072514

Date Submitted to PDQ		2003-09-30

Information Last Verified		2008-11-10

NCI Grant/Contract Number		CA15704

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.