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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients who live longer than 12 months

Outcome Description:

Kaplan-Meier curves will be used will be used to describe overall survival and failure-free survival.

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Ravi Salgia

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02819

NCT ID:

NCT00042978

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • Recurrent Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606