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About
Drugs used in chemotherapy such as gemcitabine use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of gemcitabine by making cancer cells more sensitive to the drug. This phase I trial is studying the side effects and best dose of oblimersen and gemcitabine in treating patients with metastatic or unresectable solid tumors or lymphoma
Full description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and dose-limiting toxicity of oblimersen and gemcitabine in patients with advanced solid tumor or lymphoma.
II. Determine the effect of oblimersen on the pharmacokinetics and pharmacodynamics of gemcitabine in these patients.
III. Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oblimersen and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients receive treatment at the MTD.
PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 6-8 months.
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Inclusion and exclusion criteria
Inclusion Criteria:
Histologically confirmed malignancy for which there is no standard or effective curative or palliative therapy
Measurable or evaluable nonmeasurable disease
No known brain metastases
Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%
More than 3 months
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 mg/dL
AST and ALT no greater than 2.5 times upper limit of normal
No history of portal hypertension
No history of cirrhosis or hepatitis
No radiographic evidence of cirrhosis and/or varices
Creatinine normal
Creatinine clearance at least 60 mL/min
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior allergic reaction attributed to compounds of similar chemical or biological composition to oblimersen or other study agents
No other concurrent uncontrolled illness that would preclude study participation
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No concurrent prophylactic colony-stimulating factors such as filgrastim (G-CSF) or sargramostim (GM-CSF)
Concurrent interventional growth factors allowed
Concurrent epoetin alfa allowed
No more than 3 prior chemotherapy regimens
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
More than 2 weeks since prior hormonal therapy
Concurrent megestrol for anorexia/cachexia allowed
No prior pelvic or whole abdominal radiotherapy
More than 4 weeks since prior radiotherapy
More than 4 weeks since prior major surgery
Recovered from prior therapy
More than 4 weeks since prior investigational therapy
No prior oblimersen
No other concurrent investigational agents
No other concurrent anticancer therapy
No concurrent combination antiretroviral therapy for HIV-positive patients
Primary purpose
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15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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