Clinical trial NCT00054210: Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2003-02-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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 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.

Detailed 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.

Eligibility criteria: 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

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