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Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: April 4, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005032
  Purpose

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 Intervention Phase
Lung Cancer
Biological: oblimersen sodium
Drug: paclitaxel
Phase I
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Paclitaxel Oblimersen sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005032

Locations
United States, Illinois
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Division of Hematology/Oncology
Park Ridge, Illinois, United States, 60068
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States, 46617
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Charles M. Rudin, MD, PhD University of Chicago
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067557, UCCRC-10017, NCI-T98-0091
Study First Received: April 6, 2000
Last Updated: April 4, 2009
ClinicalTrials.gov Identifier: NCT00005032     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Antimitotic Agents
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Tubulin Modulators
Neuroepithelioma
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009