Clinical trial NCT00510445: Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
Official title: A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Keywords: Non Small Cell Lung Cancer
Advanced Non Small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer
Lead sponsor: Geron Corporation
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 27
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 purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.

Detailed description: GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of NSCLC
* Stage IIIb with pleural effusion, Stage IV, or recurrent disease
* Measurable or evaluable disease by RECIST criteria
* ECOG performance status 0-1
* Adequate hepatic/renal function and platelet count
* If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%

Exclusion Criteria:

* More than 2 prior chemotherapy regimens for metastatic disease (prior adjuvant chemotherapy is allowed)
* Tumor progression during treatment with paclitaxel (refractory to paclitaxel)
* Taxane-based regimen within 12 weeks
* Any systemic therapy for cancer within 4 weeks
* Anti-platelet therapy within 2 weeks, other than low dose aspirin prophylaxis therapy
* Therapeutic anticoagulation therapy except for low dose warfarin (eg, 1 mg by mouth per day)
* Radiation therapy within 3 weeks
* Major surgery within 4 weeks (central line placement is allowed)
* Prolongation of PT or aPTT \> the ULN or fibrinogen \< the LLN
* History of or active central nervous system metastatic disease
* Any other active malignancy
* Active or chronically recurrent bleeding (eg, active peptic ulcer disease)
* Clinically significant infection
* Active autoimmune disease requiring immunosuppressive therapy
* Clinically significant cardiovascular disease or condition

Primary outcomes:
measure: Safety and MTD
timeFrame: First 3 weeks
Secondary outcomes:
measure: PK and efficacy
timeFrame: Baseline to end of treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
Study officials:
References: