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Carboplatin and Etoposide With or Without Oblimersen Sodium in Treating Patients With Extensive Stage Small Cell Lung Cancer

Primary Purpose

Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oblimersen sodium
carboplatin
etoposide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients must have histologically or cytologically documented small cell carcinoma of the bronchus; those who are being considered for combined modality therapy with chemotherapy and radiation are NOT eligible for this study The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy No prior chemotherapy for small cell lung cancer (SCLC) Radiation therapy must have been completed at least 1 week before initiation of protocol therapy Measurable disease is defined as having at least one lesion that can be accurately measured in at least one dimension; the longest diameter of the lesion must be >= 20 mm with conventional techniques or >= 10 mm with spiral computed tomography (CT) scan; lesions that are not considered measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Non-pregnant and non-nursing No active central nervous system (CNS) metastases; patients with CNS metastases will be eligible if they have completed a course of CNS radiotherapy if clinically indicated and recover from the toxicity of radiotherapy prior to enrollment, with a minimum of one week after completion of radiation No medical conditions such as uncontrolled infection (including human immunodeficiency virus [HIV]), psychiatric illness which would prevent the patient from giving informed consent, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient No patients with a "currently active" second malignancy other than nonmelanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse Granulocytes >= 1,500/ul Platelet count >= 100,000/ul Bilirubin within normal limits Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x upper limits of normal Prothrombin time (PT) =< 1.5 x upper limits of normal Partial thromboplastin time (PTT) =< 1.5 x upper limits of normal Creatinine =< 2 mg/dl or creatinine clearance >= 60 ml/min

Sites / Locations

  • Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (oblimersen sodium, carboplatin, and etoposide)

Arm II (carboplatin and etoposide)

Arm Description

Patients receive oblimersen sodium IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 60 minutes on days 6-8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Percentage of patients who live longer than 12 months
Kaplan-Meier curves will be used will be used to describe overall survival and failure-free survival.

Secondary Outcome Measures

Incidence of grade 4 neutropenia or thrombocytopenia associated with the administration of oblimersen sodium assessed using Common Toxicity Criteria (CTC) version 2.X
The frequency of toxicity occurrence will be tabulated by the most severe occurrence.

Full Information

First Posted
August 5, 2002
Last Updated
January 11, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00042978
Brief Title
Carboplatin and Etoposide With or Without Oblimersen Sodium in Treating Patients With Extensive Stage Small Cell Lung Cancer
Official Title
A Randomized Phase II Study Of Carboplatin And Etoposide With Or Without G3139 (NSC #683428, IND #58842) In Patients With Extensive Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial studies how well carboplatin and etoposide with or without oblimersen sodium works in treating patients with extensive stage small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as oblimersen sodium, may stimulate the immune system in different ways and stop cancer cells from growing. Giving carboplatin and etoposide together with oblimersen sodium may kill not tumor cells
Detailed Description
PRIMARY OBJECTIVES: I. To assess the percentage of patients with extensive stage small cell lung cancer treated with G3139 (oblimersen sodium), carboplatin, and etoposide who live longer than 12 months. SECONDARY OBJECTIVES: I. To assess the response rate of patients treated with G3139, carboplatin, and etoposide. II. To assess the toxicity of the combination of G3139, carboplatin, and etoposide. III. To compare the toxicity observed to that seen in a cohort of patients treated with carboplatin and etoposide alone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oblimersen sodium intravenously (IV) continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 60 minutes on days 6-8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (oblimersen sodium, carboplatin, and etoposide)
Arm Type
Experimental
Arm Description
Patients receive oblimersen sodium IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 60 minutes on days 6-8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (carboplatin and etoposide)
Arm Type
Active Comparator
Arm Description
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Other Intervention Name(s)
augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
EPEG, VP-16, VP-16-213
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Percentage of patients who live longer than 12 months
Description
Kaplan-Meier curves will be used will be used to describe overall survival and failure-free survival.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Incidence of grade 4 neutropenia or thrombocytopenia associated with the administration of oblimersen sodium assessed using Common Toxicity Criteria (CTC) version 2.X
Description
The frequency of toxicity occurrence will be tabulated by the most severe occurrence.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must have histologically or cytologically documented small cell carcinoma of the bronchus; those who are being considered for combined modality therapy with chemotherapy and radiation are NOT eligible for this study The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy No prior chemotherapy for small cell lung cancer (SCLC) Radiation therapy must have been completed at least 1 week before initiation of protocol therapy Measurable disease is defined as having at least one lesion that can be accurately measured in at least one dimension; the longest diameter of the lesion must be >= 20 mm with conventional techniques or >= 10 mm with spiral computed tomography (CT) scan; lesions that are not considered measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Non-pregnant and non-nursing No active central nervous system (CNS) metastases; patients with CNS metastases will be eligible if they have completed a course of CNS radiotherapy if clinically indicated and recover from the toxicity of radiotherapy prior to enrollment, with a minimum of one week after completion of radiation No medical conditions such as uncontrolled infection (including human immunodeficiency virus [HIV]), psychiatric illness which would prevent the patient from giving informed consent, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient No patients with a "currently active" second malignancy other than nonmelanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse Granulocytes >= 1,500/ul Platelet count >= 100,000/ul Bilirubin within normal limits Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x upper limits of normal Prothrombin time (PT) =< 1.5 x upper limits of normal Partial thromboplastin time (PTT) =< 1.5 x upper limits of normal Creatinine =< 2 mg/dl or creatinine clearance >= 60 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Salgia
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

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Carboplatin and Etoposide With or Without Oblimersen Sodium in Treating Patients With Extensive Stage Small Cell Lung Cancer

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