Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

NCT00254904

Carcinoma, Non-Small-Cell Lung

TERMINATED PHASE3

Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer

NCT00192036

Non Small Cell Lung Cancer

COMPLETED PHASE2

Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00006116

Lung Cancer

UNKNOWN PHASE2

A Study With Gemcitabine, Cisplatin, and LY293111 in Non-Small Cell Lung Cancer

NCT00069875

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE2

Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer

NCT00191763

Carcinoma, Non-Small-Cell-Lung Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Non-Small-Cell Lung (NSCLC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AG-013736/Cisplatin/Gemcitabine

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

AG-013736 5 mg tablets orally, twice daily, until disease progression

gemcitabine

Intervention Type DRUG

200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m\^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles

cisplatin

Intervention Type DRUG

1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m\^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AG-013736

AG-013736 5 mg tablets orally, twice daily, until disease progression

Intervention Type DRUG

gemcitabine

200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m\^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles

Intervention Type DRUG

cisplatin

1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m\^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

axitinib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
* Candidate for primary treatment with cisplatin and gemcitabine
* Presence of measurable disease by RECIST
* Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1

Exclusion Criteria

* Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
* One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
* History of hemoptysis \> ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
* NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
* Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
* Untreated brain metastases.
* Need for therapeutic anticoagulation, regular use of aspirin (\> 325 mg/day), NSAID or other medications known to inhibit platelet function.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No