Clinical trial NCT00017251: Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Official title: A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Extensive Stage Small Cell Lung Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0
timeFrame: Up to 3 years
measure: Maximally tolerated dose of oblimersen sodium
timeFrame: 8 days
Secondary outcomes:
measure: Potential antitumor activity (responses to therapy)
timeFrame: Up to 3 years
measure: Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level
timeFrame: Day 6 and 8
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Charles Rudin
role: PRINCIPAL_INVESTIGATOR
References: