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A Phase I/II Study of G3139, a BCL-2 Antisense Oligonucleotide, Combined With Paclitaxel for the Treatment of Recurrent Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase I/II Study of G3139, a BCL-2 Antisense Oligonucleotide, Combined With Paclitaxel for the Treatment of 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability of dosing

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Charles M. Rudin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

10117

NCT ID:

NCT00005032

Start Date:

April 2000

Completion Date:

September 2001

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Evanston Northwestern Health CareEvanston, Illinois  60201
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
University of Illinois at ChicagoChicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C.Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C.South Bend, Indiana  46617
Division of Hematology/OncologyPark Ridge, Illinois  60068