Clinical trial NCT00352690: A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
Official title: A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: CTI BioPharma
First posted: 2006-07-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas).
* Eligible Disease Stages: Inoperable IIIA and Selected IIIB
* Local radiation oncologist must approve patient eligibility prior to entry on study.
* Patients must have measurable disease.
* Prior Therapy:

  * ≥ 2 weeks since formal exploratory thoracotomy.
  * No prior chemotherapy or radiation therapy for NSCLC.
* ECOG performance status 0-1
* Required Initial Laboratory Values (must be submitted within 16 days prior to registration):

  * Granulocytes ≥ 1,500/µl
  * Platelets ≥ 100,000/µl
  * Calculated Creatinine Clearance ≥ 20 cc/min
  * Bilirubin \< 1.5 mg/dl
  * AST (SGOT) \< 2 x ULN
  * INR \> 0.8 \< 1.2\* \*Values apply exclusively to patients not being treated with warfarin. Values for patients being treating with warfarin should fall within the following therapeutic range: \> 2.0 \< 3.0.

Exclusion Criteria:

* Currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
* Pregnant or nursing because of significant risk to the fetus/infant.
* Age \<18 years.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* No HIV-positive patients receiving combination anti-retroviral therapy. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy
* One-second forced expiratory volume (FEV1) \<50% or hemoglobin-corrected carbon monoxide diffusion capacity (DLCO) \<50% of predicted, as measured within 21 days of study entry
* Symptoms of esophageal dysfunction (dysphagia, odynophagia, or inability to swallow solid food) within 4 weeks prior to study randomization. Patients must not require prophylactic placement of percutaneous enterogastrostomy (PEG) tube or other non-oral nutritional supplement methods
* Weight loss of \> 10% in the past 3 months.

Primary outcomes:
measure: Overall Survival (OS) Rate
timeFrame: 6 months
measure: Overall Survival (OS)
timeFrame: Completion of follow-up (follow-up ranged from 3 months to 6 years)
Secondary outcomes:
measure: Failure-free Survival (FFS) Rate
timeFrame: 6 months
measure: Failure-free Survival (FFS)
timeFrame: Completion of follow-up (follow-up ranged from 3 months to 6 years)
measure: Response Rates
timeFrame: 4 years
measure: Incidence and Severity of Radiation-induced Esophagitis
timeFrame: 30 days following completion of treatment (approximately 114 days)
measure: Incidence and Severity of Radiation-induced Pneumonitis
timeFrame: 30 days following completion of treatment (approximately 114 days)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical College
state: Illinois
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
city: Minneapolis
country: United States
facility: University of Minnesota, Twin Cities
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri, Columbia
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: Washington University School of Medicine
name: Ramaswamy Govindan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: