NCT Number: NCT00005032
Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bcl-2 antisense oligodeoxynucleotide G3139 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.
PURPOSE: Phase I/II trial to study the effectiveness of bcl-2 antisense oligodeoxynucleotide G3139 and paclitaxel in treating patients who have recurrent small cell lung cancer.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
About this study
OBJECTIVES: I. Assess the toxicity and feasibility of paclitaxel administration during continuous intravenous bcl-2 antisense oligodeoxynucleotide G3139 in patients with recurrent small cell lung cancer. II. Evaluate the clinical response of this patient population when treated with this regimen. III. Evaluate the correlation between bcl-2 expression in these patients and efficacy of this therapy.
OUTLINE: Patients are stratified according to whether they have received prior taxane therapy (yes vs no). Patients receive bcl-2 antisense oligodeoxynucleotide G3139 IV continuously on days 1-6 followed by 2 weeks of rest. Paclitaxel IV is administered over 3 hours on day 6 of each course. Treatment continues for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Intrapatient dose escalation is allowed. Patients are followed until death.
PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 12-18 months.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer Prior therapy including either cisplatin or carboplatin with progression either on therapy or within 3 months of completing therapy Bidimensionally measurable disease on CT scan or x-ray, not limited to the CNS No active CNS disease CNS metastasis allowed if measurable disease outside of CNS and completed a course of CNS radiotherapy if clinically indicated and recovered
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Zubrod 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT/AST no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No evidence of heart block greater than first degree, bundle branch block, or ventricular or supraventricular arrhythmia on EKG No clinical evidence of congestive heart failure, angina, or documented myocardial infarction within past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known hypersensitivity to Cremaphor EL No other significant concurrent medical or psychiatric condition that might place patient at increased risk from study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to only site of measurable disease or to greater than 20% of bone marrow Surgery: Not specified Other: No other concurrent experimental drugs or cancer therapy
Treatment and study plan
paclitaxel
DrugPrimary outcomes
-
Tolerability of dosing
Time frame: 3 years
Sponsors and collaborators
Lead sponsor
University of Chicago
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
A Phase I/II Study of G3139, a BCL-2 Antisense Oligonucleotide, Combined With Paclitaxel for the Treatment of Recurrent Small Cell Lung Cancer
Important dates
- Study start
- 2000
- Primary completion
- 2001
- Study completion
- 2001
- First posted
- Jun 4, 2004
- Registry last updated
- Feb 11, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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