Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

NCT00054197 | Terminated Phase 3

• 2 other identifiers: CTI-PGT304CDR0000269908
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of gemcitabine or vinorelbine in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

gemcitabine hydrochloride DRUG

paclitaxel poliglumex DRUG

vinorelbine tartrate DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: * Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery * Stage IIIB and not a candidate for combined modality therapy * Stage IV * No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology * Cytological diagnosis must be based on the following: * No cellular diagnosis by sputum cytology alone * Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable * Measurable or nonmeasurable disease * Brain metastases allowed provided patient received prior standard antitumor therapy for CNS metastases (e.g., whole brain radiotherapy, stereotactic radioablation, or surgery) and the following conditions are met: * Neurologic function stable for at least 2 weeks before study entry * Off steroid therapy or on a tapering regimen * Recovered from prior therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin) Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No unstable angina * No myocardial infarction within the past 6 months * Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry Neurologic * See Disease Characteristics * No neuropathy greater than grade 1 * No evidence of unstable neurologic symptoms within the past 4 weeks (2 weeks for neurologic symptoms due to brain metastases) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide) * No clinically significant active infection * No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer * No other unstable medical conditions * No circumstance that would preclude study completion or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No prior systemic biologic agent for lung cancer Chemotherapy * See Disease Characteristics * No prior systemic chemotherapy for lung cancer including radiosensitizing agents Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics * No concurrent radiotherapy Surgery * See Disease Characteristics * Recovered from prior major surgery Other * More than 12 weeks since prior participation in any research study or treatment with investigational drugs * Recovered from prior investigational therapy or stable for 4 weeks before study treatment * No other concurrent investigational drugs * No other concurrent systemic antitumor therapy * No concurrent amifostine * Concurrent bisphosphonates allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• CTI BioPharma: lead

Study Sites (10)

Cooper Green Hospital

Birmingham, Alabama, 35233, United States

Location

Medical Oncology/Hematology

Gilroy, California, 95020, United States

Location

Northwest Oncology and Hematology Associates

Coral Springs, Florida, 33065, United States

Location

Midwest Cancer Research Group, Incorporated

Skokie, Illinois, 60077, United States

Location

Medschool Associates North

Reno, Nevada, 89502, United States

Location

New York Oncology Hematology, P.C. - Latham

Latham, New York, 12110-0610, United States

Location

Clinical Research Services

Bismarck, North Dakota, 58501, United States

Location

Charleston Hematology-Oncology, P.A.

Charleston, South Carolina, 29403, United States

Location

Western Washington Medical Group

Everett, Washington, 98201, United States

Location

Western Washington Oncology, Incorporated

Olympia, Washington, 98502, United States

Location

Related Publications (1)

• O'Brien ME, Socinski MA, Popovich AY, Bondarenko IN, Tomova A, Bilynsky BT, Hotko YS, Ganul VL, Kostinsky IY, Eisenfeld AJ, Sandalic L, Oldham FB, Bandstra B, Sandler AB, Singer JW. Randomized phase III trial comparing single-agent paclitaxel Poliglumex (CT-2103, PPX) with single-agent gemcitabine or vinorelbine for the treatment of PS 2 patients with chemotherapy-naive advanced non-small cell lung cancer. J Thorac Oncol. 2008 Jul;3(7):728-34. doi: 10.1097/JTO.0b013e31817c6b68.

  PMID: 18594318 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; paclitaxel poliglumex; Vinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Meghann Smith

  PPD, Incorporated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: January 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

US (10)