Combination Chemotherapy in Hodgkin's Disease or Non-Hodgkin's Lymphoma Not Responding to Previous Treatment

Lymphoma Clinical Trial

Official title:

A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014209
• Other study ID #: LY10
• Secondary ID: LILLY-CAN-NCIC-L
• Status: Completed
• Phase: Phase 2
• Start date: December 12, 2000
• Est. completion date: February 10, 2009

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to previous treatment.

Description:

OBJECTIVES:

• Determine the efficacy of gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory Hodgkin's disease or aggressive non-Hodgkin's lymphoma.

• Determine the qualitative and quantitative toxicity of this regimen in these two patient populations.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (Hodgkin's disease vs non-Hodgkin's lymphoma).

Patients receive oral dexamethasone on days 1-4, cisplatin IV over 1 hour on day 1, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 44-88 patients (22-44 per stratum) will be accrued for this study within 4-10 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 10, 2009
• Est. primary completion date: July 15, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed Hodgkin's disease OR

• Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large B-cell, or T-cell rich B-cell NHL)

• No prior diagnosis of low-grade NHL

• No histologic evidence of transformation from indolent to aggressive histology

• Bidimensionally measurable disease that is clinically or radiologically documented

• Bone lesions not considered bidimensionally measurable

• Lymph nodes at least 1.5 cm by 1.5 cm OR

• Other non-nodal lesions at least 1 cm by 1 cm

• Recurrent or refractory to 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin)

• No known CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST or ALT no greater than 2.5 times ULN

Renal:

• Creatinine less than 1.6 mg/dL

Cardiovascular:

• No significant cardiac dysfunction or cardiovascular disease

Other:

• HIV negative

• No other concurrent or prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

• No other serious illness or medical condition that would preclude study

• No active uncontrolled bacterial, fungal, or viral infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior stem cell transplantation

• No concurrent monoclonal antibody therapy

• No concurrent growth factors during the first course of study

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior IV chemotherapy

• No prior cisplatin or gemcitabine

• No prior high-dose chemotherapy

• No other concurrent cytotoxic therapy

Endocrine therapy:

• No concurrent corticosteroids, except for physiologic replacement

Radiotherapy:

• No prior radiotherapy to more than 25% of functioning bone marrow

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• At least 2 weeks since prior major surgery

Other:

• No other concurrent anti-cancer therapy or experimental therapy

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• cisplatin

• dexamethasone

• gemcitabine hydrochloride

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Moncton Hospital	Moncton	New Brunswick
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Humber River Regional Hospital	Weston	Ontario
Canada	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group	Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Baetz T, Belch A, Couban S, Imrie K, Yau J, Myers R, Ding K, Paul N, Shepherd L, Iglesias J, Meyer R, Crump M. Gemcitabine, dexamethasone and cisplatin is an active and non-toxic chemotherapy regimen in relapsed or refractory Hodgkin's disease: a phase II — View Citation

Crump M, Baetz T, Couban S, Belch A, Marcellus D, Howson-Jan K, Imrie K, Myers R, Adams G, Ding K, Paul N, Shepherd L, Iglesias J, Meyer R. Gemcitabine, dexamethasone, and cisplatin in patients with recurrent or refractory aggressive histology B-cell non- — View Citation