This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.
Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. A variety of 'salvage chemotherapy' treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Royal Hobart Hospital
To evaluate the efficacy (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim).
Time frame: After two cycles and after four cycles
To evaluate safety,
Time frame: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
relapse free survival,
Time frame: After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
overall survival,
Time frame: every 3 or 4 months for 12 months. Then every 6 months.
and planned dose-on-time.
Time frame: After two cycles and after four cycles
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Hobart, Tasmania, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Frankston Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia