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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00551733
• Other study ID #: CTI-PGT-07-00400
• Secondary ID: CDR0000573340EUD
• Status: Terminated
• Phase: Phase 3
• Start date: August 2007
• Est. completion date: December 25, 2007

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, 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: December 25, 2007
• Est. primary completion date: December 25, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• carboplatin
Given IV
• paclitaxel
Given IV
• paclitaxel poliglumex
Given IV

Locations

Country	Name	City	State
United States	Cancer Outreach Associates - Abingdon	Abingdon	Virginia
United States	Lone Star Oncology - Austin	Austin	Texas
United States	Southwest Regional Cancer Center - Central	Austin	Texas
United States	Vita Hematology Oncology at St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	Lincoln Medical and Mental Health Center	Bronx	New York
United States	Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center	Burbank	California
United States	Blood and Cancer Center, Incorporated	Canfield	Ohio
United States	Aultman Cancer Center at Aultman Hospital	Canton	Ohio
United States	Rush Cancer Institute at Rush University Medical Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Family Cancer Center, PLLC - Collierville	Collierville	Tennessee
United States	Columbia Comprehensive Cancer Care Clinic	Columbia	Missouri
United States	Mary Crowley Medical Research Center at Sammons Cancer Center	Dallas	Texas
United States	Southwest Cancer Care - Escondido	Escondido	California
United States	Broward Oncology Associates	Fort Lauderdale	Florida
United States	West Michigan Regional Cancer and Blood Center	Free Soil	Michigan
United States	Mid-South Cancer Center	Germantown	Tennessee
United States	Cancer Centers of the Carolinas - Eastside	Greenville	South Carolina
United States	Hattiesburg Clinic, PA at Forrest General	Hattiesburg	Mississippi
United States	Horizon Institute for Clinical Research	Hollywood	Florida
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Kansas City Cancer Centers - South	Kansas City	Missouri
United States	Las Vegas Cancer Center	Las Vegas	Nevada
United States	Clinical Trials and Research Associates, Incorporated	Montebello	California
United States	Hematology Oncology Consultants - Naperville	Naperville	Illinois
United States	Cancer Center of Indiana	New Albany	Indiana
United States	Utah Hematology Oncology, PC	Ogden	Utah
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Olympia Fields	Illinois
United States	Veterans Affairs Medical Center - Reno	Reno	Nevada
United States	Saint Louis University Cancer Center	Saint Louis	Missouri
United States	Scottsdale Medical Specialists	Scottsdale	Arizona
United States	Cell Therapeutics, Incorporated	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Newland Medical Associates PC - Southfield	Southfield	Michigan
United States	Stanford Cancer Center	Stanford	California
United States	Richmond University Medical Center	Staten Island	New York
United States	Providence Medical Group	Terre Haute	Indiana
United States	New York Medical College	Valhalla	New York
United States	Family Medicine of Vincennes Clinical Trial Center	Vincennes	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Langer CJ, O'Byrne KJ, Socinski MA, Mikhailov SM, Lesniewski-Kmak K, Smakal M, Ciuleanu TE, Orlov SV, Dediu M, Heigener D, Eisenfeld AJ, Sandalic L, Oldham FB, Singer JW, Ross HJ. Phase III trial comparing paclitaxel poliglumex (CT-2103, PPX) in combinati — View Citation

Outcome

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