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

NCT00352690 | Terminated Phase 2 Results DMC

• 1 other identifier: 05-1195
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 8

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS) Rate

  * OS = time from patient registration to death of all causes * Estimated using Kaplan Meier

  6 months

• 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)

Secondary Outcomes (5)

• Failure-free Survival (FFS) Rate

  6 months

• Failure-free Survival (FFS)

  Completion of follow-up (follow-up ranged from 3 months to 6 years)

• Response Rates

  4 years

• Incidence and Severity of Radiation-induced Esophagitis

  30 days following completion of treatment (approximately 114 days)

• Incidence and Severity of Radiation-induced Pneumonitis

  30 days following completion of treatment (approximately 114 days)

Study Arms (2)

Cohort 1 (first 12 eligible patients)

OTHER

Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Drug: Paclitaxel poliglumex; Drug: Carboplatin; Radiation: External beam radiation therapy

Cohort 2 (remaining patients)

EXPERIMENTAL

Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Drug: Paclitaxel poliglumex; Drug: Carboplatin; Radiation: External beam radiation therapy

Interventions

Paclitaxel poliglumex DRUG

Also known as: Xyotax

Cohort 1 (first 12 eligible patients); Cohort 2 (remaining patients)

Carboplatin DRUG

Also known as: Paraplatin

Cohort 1 (first 12 eligible patients); Cohort 2 (remaining patients)

External beam radiation therapy RADIATION

Cohort 1 (first 12 eligible patients); Cohort 2 (remaining patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• CTI BioPharma: collaborator

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Rush University Medical College

Chicago, Illinois, United States

Location

University of Kansas

Lawrence, Kansas, 66045, United States

Location

University of Minnesota, Twin Cities

Minneapolis, Minnesota, United States

Location

University of Missouri, Columbia

Columbia, Missouri, 65211, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

paclitaxel poliglumex; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Limitations and Caveats

(3) grade 5 serious adverse events occurred and led to the study closing early for the safety of participants.

Results Point of Contact

• Title: Ramaswamy Govindan, M.D.
• Organization: Washington University School of Medicine

rgovinda@dom.wustl.edu

314-362-5737

Study Officials

• Ramaswamy Govindan, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2006
• First Posted: July 17, 2006
• Study Start: April 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 12, 2016
• Results First Posted: May 27, 2015

Record last verified: 2016-10

Locations

US (8)