Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Sponsor

CTI BioPharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT00551733

Collaborator

(none)

450

Enrollment

Locations

Arms

4.8

Actual Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving carboplatin together with paclitaxel poliglumex is more effective than giving carboplatin together with paclitaxel in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel poliglumex to see how well they work compared with carboplatin and paclitaxel in treating women with stage III, stage IV, or recurrent non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin Drug: paclitaxel Drug: paclitaxel poliglumex	Phase 3

Detailed Description

OBJECTIVES:

Primary

Compare the overall survival of patients with chemotherapy-naïve stage IIIB or IV or recurrent non-small cell lung cancer treated with paclitaxel poliglumex and carboplatin vs paclitaxel and carboplatin.

Secondary

Compare the progression-free survival of women treated with these regimens.
Compare the disease control in women treated with these regimens.
Compare the clinical benefit in women treated with these regimens.
Compare the response rate in women treated with these regimens.
Compare the quality of life of women treated with these regimens.
Compare the safety and tolerability in women treated with these regimens.

OUTLINE: This is a multicenter study.

Patients are stratified according to age (≥ 60 vs < 60 years old), geographical location (United States of America, Canada, or Australia vs the rest of the world), extent of disease (independent of brain metastases, i.e., brain metastases are not considered in determining extent of disease) (intrathoracic disease only vs extrathoracic disease), and ECOG performance status (0 or 1 vs 2). Patients will be randomized to 1 of 2 treatment arms.

Arm I: Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1.
Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the completion of study treatment by the Pain Assessment Patient Questionnaire, the Pulmonary Symptom Index, and the Functional Assessment of Cancer Therapy- Lung Cancer Subscale (FACT-LCS) (only in countries in which a validated translation is currently available).

After completion of study therapy, patients are followed at least monthly.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol >30 pg/mL

Actual Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Dec 25, 2007

Actual Study Completion Date :

Dec 25, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Drug: carboplatin Given IV Drug: paclitaxel poliglumex Given IV
Active Comparator: Arm II Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Drug: carboplatin Given IV Drug: paclitaxel Given IV

Arm

Intervention/Treatment

Experimental: Arm I

Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: carboplatin

Given IV

Drug: paclitaxel poliglumex

Given IV

Active Comparator: Arm II

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: carboplatin

Given IV

Drug: paclitaxel

Given IV

Outcome Measures

Primary Outcome Measures

Overall survival []

Secondary Outcome Measures

Progression-free survival []
Disease control []
Clinical benefit as defined by use of opiates, growth factors, and transfusions, []
Response rate as assessed by complete response or partial response per RECIST criteria []
Quality of life as assessed by Fact-LCS Scores and Pulmonary Symptom Index (PSI) Scores and Pain Scores []
Safety as assessed by NCI CTCAE Version 3 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
Cytologic specimens obtained by brushings, washings, or needle aspiration of a defined lesion or from a pleural effusion are acceptable; sputum cytology alone is not acceptable for determining cell type
Must meet one of the following criteria:
Recurrent disease following completion of radiation or surgery
Stage IIIB disease and not a candidate for combined modality therapy (primary radiation therapy or surgery)
Stage IV disease
Patients may have either measurable or nonmeasurable disease according to RECIST criteria
Baseline estradiol > 30 pg/mL
Patients on hormone replacement therapy are eligible provided baseline estradiol

30 pg/mL

Patients with known brain metastases must have received standard antitumor treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS metastases as defined by the site's institutional standards
Neurologic function must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen
Patients must have recovered from therapy for their brain metastases with no evidence of significant unstable neurological symptoms within the 4 weeks before study randomization
No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology

PATIENT CHARACTERISTICS:

Female
ECOG performance score 0-2
Life expectancy ≥ 12 weeks
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL (may be achieved with transfusion)
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 1.5 times ULN (CTC grade 1) (patients with Gilbert syndrome or other hereditary bilirubin defects may be included regardless of bilirubin levels)
SGOT and SGPT ≤ 2.5 times ULN (CTC grade 0 or 1) (5 times ULN [CTC grade 0 to 2] if due to liver metastases)
Alkaline phosphatase ≤ 2.5 times ULN except for elevated alkaline phosphatase with laboratory documentation that demonstrates bone origin
No pregnant women or nursing mothers
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation
No known hypersensitivity to study drugs or excipients
Meets all of the following criteria:
No weight loss > 10% in previous 6 months
Lactate dehydrogenase (LDH) ≤ 600 IU/L (central laboratory) regardless of weight loss
LDH ≤ 400 IU/L (central laboratory) and no weight loss ≥ 5% in previous 6 months
BMI ≤ 35
No concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer
No neuropathy grade 2 or greater
No clinically significant active infection for which active therapy is underway
No unstable medical conditions including unstable angina or myocardial infarction within the past 6 months
Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable
No circumstance that would preclude completion of the study or the required follow-up

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from major surgery
At least 7 days since prior local palliative radiotherapy
At least 30 days since prior radiation therapy with curative intent
At least 4 weeks since prior investigational therapy, unless local requirements are more stringent
No prior systemic chemotherapy for the treatment of lung cancer, including systemic radiosensitizers used to treat brain metastases or any biologic agents
No concurrent non-protocol-specified systemic antitumor therapy
No concurrent amifostine, investigational agents, other cytotoxic agents for this disease
No concurrent radiotherapy (with the exception of radiotherapy for brain or bone metastases for palliative purposes or radiotherapy for a condition other than NSCLC that was ongoing at the time of randomization)
Patients receiving palliative radiotherapy (treatment for symptomatic metastatic disease) may be treated while on study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Medical Specialists	Scottsdale	Arizona	United States	85258
2	Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center	Burbank	California	United States	91505
3	Southwest Cancer Care - Escondido	Escondido	California	United States	92025-4404
4	Clinical Trials and Research Associates, Incorporated	Montebello	California	United States	90640
5	Stanford Cancer Center	Stanford	California	United States	94305-5824
6	Broward Oncology Associates	Fort Lauderdale	Florida	United States	33308-1414
7	Horizon Institute for Clinical Research	Hollywood	Florida	United States	33021
8	Rush Cancer Institute at Rush University Medical Center	Chicago	Illinois	United States	60612
9	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
10	Hematology Oncology Consultants - Naperville	Naperville	Illinois	United States	60565
11	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Olympia Fields	Illinois	United States	60461
12	Cancer Center of Indiana	New Albany	Indiana	United States	47150
13	Providence Medical Group	Terre Haute	Indiana	United States	47802
14	Family Medicine of Vincennes Clinical Trial Center	Vincennes	Indiana	United States	47591
15	West Michigan Regional Cancer and Blood Center	Free Soil	Michigan	United States	49411
16	Newland Medical Associates PC - Southfield	Southfield	Michigan	United States	48275
17	Hattiesburg Clinic, PA at Forrest General	Hattiesburg	Mississippi	United States	39401
18	Columbia Comprehensive Cancer Care Clinic	Columbia	Missouri	United States	65201
19	Kansas City Cancer Centers - South	Kansas City	Missouri	United States	64131
20	Saint Louis University Cancer Center	Saint Louis	Missouri	United States	63110
21	Las Vegas Cancer Center	Las Vegas	Nevada	United States	89102
22	Veterans Affairs Medical Center - Reno	Reno	Nevada	United States	89520
23	Lincoln Medical and Mental Health Center	Bronx	New York	United States	10451
24	Richmond University Medical Center	Staten Island	New York	United States	10310-1699
25	New York Medical College	Valhalla	New York	United States	10595
26	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
27	Blood and Cancer Center, Incorporated	Canfield	Ohio	United States	44406
28	Aultman Cancer Center at Aultman Hospital	Canton	Ohio	United States	44710-1799
29	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45219
30	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
31	Vita Hematology Oncology at St. Luke's Hospital	Bethlehem	Pennsylvania	United States	18015
32	Cancer Centers of the Carolinas - Eastside	Greenville	South Carolina	United States	29615
33	Family Cancer Center, PLLC - Collierville	Collierville	Tennessee	United States	38077
34	Mid-South Cancer Center	Germantown	Tennessee	United States	38138
35	Southwest Regional Cancer Center - Central	Austin	Texas	United States	78705
36	Lone Star Oncology - Austin	Austin	Texas	United States	78759
37	Mary Crowley Medical Research Center at Sammons Cancer Center	Dallas	Texas	United States	75246
38	Utah Hematology Oncology, PC	Ogden	Utah	United States	84403
39	Cancer Outreach Associates - Abingdon	Abingdon	Virginia	United States	24211
40	Virginia Mason Medical Center	Seattle	Washington	United States	98101
41	Cell Therapeutics, Incorporated	Seattle	Washington	United States	98119