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

Lung Cancer Clinical Trial

Official title:

CT-2103/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00054210
• Other study ID #: CTI-PGT303
• Secondary ID: CDR0000269910
• Status: Terminated
• Phase: Phase 3
• Start date: January 2003
• Est. completion date: October 2004

Study information

• Verified date: October 2020
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 which regimen of chemotherapy is more effective in treating stage IIIB, stage IV, or recurrent non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Description:

OBJECTIVES:

• Compare the efficacy of polyglutamate paclitaxel (CT-2103) and carboplatin vs paclitaxel and carboplatin, in terms of duration of overall survival, in patients with stage IIIB or IV or recurrent non-small cell lung cancer who have a performance status of 2.

• Compare the disease control (percentage of patients with no disease progression for at least 12 weeks) and time to progression in patients treated with these regimens.

• Compare the response rate in patients with measurable disease treated with these regimens.

• Compare the improvement in lung cancer symptoms in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, disease stage (IV vs other), geographic location (US vs Western Europe and Canada vs the rest of the world), and prior brain metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes and carboplatin IV over 30 minutes on day 1.

• Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.

Treatment repeats in both arms every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 13 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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 neurological symptoms within the past 4 weeks (2 weeks for neurological 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 therapy 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• paclitaxel

• paclitaxel poliglumex

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
United States	Hematology and Oncology Associates of Alabama	Birmingham	Alabama
United States	Highline Medical Oncology	Burien	Washington
United States	Gabrail Cancer Center - Canton Office	Canton	Ohio
United States	Charleston Cancer Center	Charleston	South Carolina
United States	Clarksville Regional Hematology/Oncology Group	Clarksville	Tennessee
United States	Family Cancer Center	Collierville	Tennessee
United States	Columbia Comprehensive Cancer Care Clinic	Columbia	Missouri
United States	Synergy Hematology/Oncology Medical Associates	Encino	California
United States	Hattiesburg Clinic, P.A.	Hattiesburg	Mississippi
United States	Clinical Research Consultants, Inc	Hoover	Alabama
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	New Hope Cancer Centers	Hudson	Florida
United States	Silver Cross Hospital	Joliet	Illinois
United States	Las Vegas Cancer Center	Las Vegas	Nevada
United States	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia
United States	Omni Healthcare, PA	Melbourne	Florida
United States	Holy Cross Providence Cancer Center	Mission Hills	California
United States	Clinical Trials and Research Associates, Incorporated	Montebello	California
United States	MetCare Oncology	Ormond Beach	Florida
United States	Kentucky Cancer Clinic	Pikeville	Kentucky
United States	Hematology Oncology Associates of theTreasure Coast - Port St. Lucie	Port Saint Lucie	Florida
United States	Rainier Oncology	Puyallup	Washington
United States	Virginia Oncology Care P.C.	Richlands	Virginia
United States	Bond Clinic	Rolla	Missouri
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	Gross Point Medical Center	Skokie	Illinois
United States	Hematology Oncology, P.C.	Stamford	Connecticut
United States	Summit Medical Group, P.A.	Summit	New Jersey
United States	Santee Hematology Oncology	Sumter	South Carolina
United States	California Hematology/Oncology Medical Group	Torrance	California
United States	Georgia Cancer Specialists - Tucker	Tucker	Georgia
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Oklahoma Oncology, Inc. - St. John Campus	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Countries where clinical trial is conducted

United States,  Canada,