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Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00005032
First received: April 6, 2000
Last updated: February 8, 2013
Last verified: February 2013
History of Changes

April 6, 2000
February 8, 2013
April 2000
January 2001   (final data collection date for primary outcome measure)
Tolerability of dosing [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00005032 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
A Phase I/II Study of G3139, a BCL-2 Antisense Oligonucleotide, Combined With Paclitaxel for the Treatment of 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.

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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Biological: oblimersen sodium
  • Drug: paclitaxel
Experimental: Arm A
G3139 (3 mg/kg/day continuous IV infusion over 7 days every 21 days), Paclitaxel (150 mg/m2, 3 hr IV infusion on Day 6 of every 21 day cycle)
Interventions:
  • Biological: oblimersen sodium
  • Drug: paclitaxel
Rudin CM, Otterson GA, Mauer AM, Villalona-Calero MA, Tomek R, Prange B, George CM, Szeto L, Vokes EE. A pilot trial of G3139, a bcl-2 antisense oligonucleotide, and paclitaxel in patients with chemorefractory small-cell lung cancer. Ann Oncol. 2002 Apr;13(4):539-45.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2001
January 2001   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005032
10117, UCCRC-10017, NCI-T98-0091
No
University of Chicago
University of Chicago
National Cancer Institute (NCI)
Study Chair: Charles M. Rudin, MD, PhD University of Chicago
University of Chicago
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP