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A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Extensive Stage Small Cell Lung Cancer

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Trial Information

A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer


PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of oblimersen when combined with standard dose
carboplatin and etoposide in patients with previously untreated extensive stage small cell
lung cancer.

II. Determine the toxicity and feasibility of this regimen in these patients. III. Determine
potential antitumor activity of this regimen as assessed by objective response in these
patients.

OUTLINE: This is a multicenter, dose-escalation study of oblimersen (G3139).

Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6,
and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6
courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 6-12 patients will be accrued for this study within 5
months.


Inclusion Criteria:



- Histologically or cytologically confirmed extensive stage small cell lungcancer

- No active CNS disease

- CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- More than 2 months

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin normal

- AST and ALT no greater than 2.5 times upper limit of normal (ULN)

- PT and PTT no greater than 1.5 times ULN

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior allergic reactions to compounds of similar chemical or biologic composition
to study agents

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- See Disease Characteristics

- At least 1 week since prior CNS radiotherapy and recovered

- No prior radiotherapy to more than 25% of skeleton

- No other prior anticancer therapy

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- No concurrent anticoagulation therapy

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0

Outcome Description:

Data will be summarized separately for each dose level, by severity, and type of toxicity.

Outcome Time Frame:

Up to 3 years

Safety Issue:

Yes

Principal Investigator

Charles Rudin

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02387

NCT ID:

NCT00017251

Start Date:

April 2001

Completion Date:

Related Keywords:

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

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470