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

NCT00551733 | Terminated Phase 3

• 3 other identifiers: CTI-PGT-07-00400CDR0000573340EUDRACT-2007-004167-22
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 41

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (6)

• 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

Study Arms (2)

Arm I

EXPERIMENTAL

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; Drug: paclitaxel poliglumex

Arm II

ACTIVE COMPARATOR

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; Drug: paclitaxel

Interventions

carboplatin DRUG

Given IV

Arm I; Arm II

paclitaxel DRUG

Given IV

Arm II

paclitaxel poliglumex DRUG

Given IV

Arm I

Eligibility Criteria

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

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

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 (41)

Scottsdale Medical Specialists

Scottsdale, Arizona, 85258, United States

Location

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

Southwest Cancer Care - Escondido

Escondido, California, 92025-4404, United States

Location

Clinical Trials and Research Associates, Incorporated

Montebello, California, 90640, United States

Location

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

Broward Oncology Associates

Fort Lauderdale, Florida, 33308-1414, United States

Location

Horizon Institute for Clinical Research

Hollywood, Florida, 33021, United States

Location

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Hematology Oncology Consultants - Naperville

Naperville, Illinois, 60565, United States

Location

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

Olympia Fields, Illinois, 60461, United States

Location

Cancer Center of Indiana

New Albany, Indiana, 47150, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Family Medicine of Vincennes Clinical Trial Center

Vincennes, Indiana, 47591, United States

Location

West Michigan Regional Cancer and Blood Center

Free Soil, Michigan, 49411, United States

Location

Newland Medical Associates PC - Southfield

Southfield, Michigan, 48275, United States

Location

Hattiesburg Clinic, PA at Forrest General

Hattiesburg, Mississippi, 39401, United States

Location

Columbia Comprehensive Cancer Care Clinic

Columbia, Missouri, 65201, United States

Location

Kansas City Cancer Centers - South

Kansas City, Missouri, 64131, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Las Vegas Cancer Center

Las Vegas, Nevada, 89102, United States

Location

Veterans Affairs Medical Center - Reno

Reno, Nevada, 89520, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310-1699, United States

Location

Lincoln Medical and Mental Health Center

The Bronx, New York, 10451, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

Blood and Cancer Center, Incorporated

Canfield, Ohio, 44406, United States

Location

Aultman Cancer Center at Aultman Hospital

Canton, Ohio, 44710-1799, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45219, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Vita Hematology Oncology at St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

Family Cancer Center, PLLC - Collierville

Collierville, Tennessee, 38077, United States

Location

Mid-South Cancer Center

Germantown, Tennessee, 38138, United States

Location

Southwest Regional Cancer Center - Central

Austin, Texas, 78705, United States

Location

Lone Star Oncology - Austin

Austin, Texas, 78759, United States

Location

Mary Crowley Medical Research Center at Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Utah Hematology Oncology, PC

Ogden, Utah, 84403, United States

Location

Cancer Outreach Associates - Abingdon

Abingdon, Virginia, 24211, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Cell Therapeutics, Incorporated

Seattle, Washington, 98119, United States

Location

Related 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 combination with carboplatin versus standard paclitaxel and carboplatin in the treatment of PS 2 patients with chemotherapy-naive advanced non-small cell lung cancer. J Thorac Oncol. 2008 Jun;3(6):623-30. doi: 10.1097/JTO.0b013e3181753b4b.

  PMID: 18520802 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; paclitaxel poliglumex

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Fred B. Oldham, MD

  CTI BioPharma

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: October 31, 2007
• Study Start: August 1, 2007
• Primary Completion: December 25, 2007
• Study Completion: December 25, 2007
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

US (41)