A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00352690
• Other study ID #: 05-1195
• Status: Terminated
• Phase: Phase 2
• First received: July 14, 2006
• Last updated: May 7, 2015
• Start date: April 2006
• Est. completion date: June 2008

Study information

• Verified date: May 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Paclitaxel poliglumex

• Carboplatin

Radiation:
• External beam radiation therapy

Locations

Country	Name	City	State
United States	Rush University Medical College	Chicago	Illinois
United States	University of Missouri, Columbia	Columbia	Missouri
United States	University of Kansas	Lawrence	Kansas
United States	University of Minnesota, Twin Cities	Minneapolis	Minnesota
United States	University of California, San Francisco	San Francisco	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	CTI BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) Rate	OS = time from patient registration to death of all causes	6 months	No
Primary	Overall Survival (OS)	OS = time from patient registration to death of all causes	Completion of follow-up (follow-up ranged from 3 months to 6 years)	No
Secondary	Failure-free Survival (FFS) Rate	The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)	6 months	No
Secondary	Failure-free Survival (FFS)	The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)	Completion of follow-up (follow-up ranged from 3 months to 6 years)	No
Secondary	Response Rates	Overall best response using RECIST 1.0	4 years	No
Secondary	Incidence and Severity of Radiation-induced Esophagitis		30 days following completion of treatment (approximately 114 days)	Yes
Secondary	Incidence and Severity of Radiation-induced Pneumonitis		30 days following completion of treatment (approximately 114 days)	Yes

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine