Clinical trial NCT00042679: A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.
Official title: A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Pulmonary Neoplasms
Neoplasms, Lung
Keywords: Non-Small-Cell Lung Cancer
Adenocarcinoma
Carcinoma Squamous
Adult Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-08-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to determine the following:

Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear, and for how long.

If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer.

The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be associated with the combination of these three drugs.

How LY900003 is distributed and broken down by your body when it is given with carboplatin and gemcitabine.

Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down by your body.

Detailed description: Definition: The phase 2 study will provide important information regarding effects of LY900003 on safety and efficacy of patients treated with gemcitabine and carboplatin. LY900003 will be given at approximately 2 mg/kg/day for the first 14 days of a 21-day cycle. The dose and schedule for LY900003 administration are based on results of prior studies of LY900003 and are currently being used in other studies of LY900003. Gemcitabine will be administered on Days 1 and 8 at 1250 mg/m2 and carboplatin will be given on Day 1 at AUC 5.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Non-Small-Cell Lung Cancer.
* Stage IV or Stage IIIB disease.
* ECOG Performance Status of 0 or 1.
* Adequate organ function
* One unidimensionally measurable lesion.

Exclusion Criteria:

* Prior therapy for NSCLC.
* Serious concomitant disorders.
* Untreated CNS metastases.
* Uncontrolled, active infection.
* Previous LY900003/ISIS trial participation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: Berkeley
country: United States
state: California
city: Torrance
country: United States
state: California
city: Miami Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Chattanooga
country: United States
state: Tennessee
city: Lubbock
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References: