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

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00005032

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Biological: oblimersen sodium Drug: paclitaxel	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Apr 1, 2000

Actual Primary Completion Date :

Jan 1, 2001

Actual Study Completion Date :

Sep 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
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)	Biological: oblimersen sodium Drug: paclitaxel

Arm

Intervention/Treatment

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)

Biological: oblimersen sodium

Drug: paclitaxel

Outcome Measures

Primary Outcome Measures

Tolerability of dosing [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612
2	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
3	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
4	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois	United States	62526
5	Evanston Northwestern Health Care	Evanston	Illinois	United States	60201
6	Division of Hematology/Oncology	Park Ridge	Illinois	United States	60068
7	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois	United States	61602
8	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62701
9	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46885-5099
10	Michiana Hematology/Oncology P.C.	South Bend	Indiana	United States	46617
11	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210