Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

NCT00729612 | Completed Phase 2 Results DMC

• 2 other identifiers: OSU-08059NCI-2011-03196
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.

  Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Up to 5 years

Secondary Outcomes (3)

• Progression Free Survival

  Up to 5 years

• Overall Survival

  Up to 5 years

• Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0

  Up to 5 years

Study Arms (1)

Treatment (nab-paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours 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 albumin-stabilized nanoparticle formulation; Genetic: protein expression analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

Interventions

carboplatin DRUG

Treatment (nab-paclitaxel, carboplatin)

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Treatment (nab-paclitaxel, carboplatin)

protein expression analysis GENETIC

Treatment (nab-paclitaxel, carboplatin)

immunoenzyme technique OTHER

Treatment (nab-paclitaxel, carboplatin)

immunohistochemistry staining method OTHER

Treatment (nab-paclitaxel, carboplatin)

laboratory biomarker analysis OTHER

Treatment (nab-paclitaxel, carboplatin)

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: * Stage IIIB disease with malignant pleural effusion * Stage IV disease * Recurrent disease * Squamous cell histology allowed * Not eligible for curative treatment or treatment with bevacizumab * Measurable disease according to RECIST * Tumor (paraffin blocks or slides) must be available for correlative biomarker studies * No uncontrolled brain metastases (or leptomeningeal disease) * Controlled brain metastases allowed * Able to receive appropriate therapeutic radiotherapy * Able to taper off all steroids without symptoms suggestive of increased intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at least 7 days PATIENT CHARACTERISTICS: * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * ANC (absolute neutrophil count) ≥ 1.5 x 10\^9/L * Platelets ≥ 100 x 10\^9/L * Hemoglobin ≥ 9.0 g/L * Total bilirubin ≤ 1.5 mg/dL * AST (aspartate aminotransferase) and ALT (alanine aminotransferase) \< 2.5 times upper limit of normal * Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 50 mg/mL * No known HIV or hepatitis B or C * Not pregnant * Negative pregnancy test * Thrombotic or embolic event within the past 6 months allowed, provided adequately controlled with therapeutic anticoagulation * Hemoptysis allowed, provided it is not life threatening or requires palliative procedures (e.g., endobronchial therapy or radiotherapy) * No cardiac disease, including any of the following: * NYHA (New York Heart Association) class III-IV congestive heart failure * Unstable angina (angina symptoms at rest) * New onset angina (began within the past 3 months) * Myocardial infarction within the past 6 months * No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg despite optimal medical management * No peripheral neuropathy ≥ grade 2 * No active clinically serious infection \> CTCAE grade 2 * No serious non-healing wound, ulcer, or bone fracture * No significant traumatic injury within the past 4 weeks * No evidence or history of bleeding diathesis or coagulopathy * No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 2 years * Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of NSCLC allowed, however metastatic prostate cancer currently receiving hormonal therapy or chemotherapy is not allowed * No significant psychiatric illness, in the opinion of the principal investigator, that would prevent adequate informed consent or render therapy unsafe PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent therapeutic anticoagulation, \> 325 mg acetylsalicylic acid, or chronic non-steroid anti-inflammatory drug use allowed * At least 14 days since prior and no concurrent radiotherapy * More than 4 weeks since prior major surgery or open biopsy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Greg Otterson: lead
• National Comprehensive Cancer Network: collaborator
• Celgene Corporation: collaborator

Study Sites (1)

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Bertino EM, Williams TM, Nana-Sinkam SP, Shilo K, Chatterjee M, Mo X, Rahmani M, Phillips GS, Villalona-Calero MA, Otterson GA. Stromal Caveolin-1 Is Associated With Response and Survival in a Phase II Trial of nab-Paclitaxel With Carboplatin for Advanced NSCLC Patients. Clin Lung Cancer. 2015 Nov;16(6):466-74. doi: 10.1016/j.cllc.2015.05.004. Epub 2015 May 13.

  PMID: 26123189 RESULT

• Owen DH, Williams TM, Bertino EM, Mo X, Webb A, Schweitzer C, Liu T, Roychowdhury S, Timmers CD, Otterson GA. Homologous recombination and DNA repair mutations in patients treated with carboplatin and nab-paclitaxel for metastatic non-small cell lung cancer. Lung Cancer. 2019 Aug;134:167-173. doi: 10.1016/j.lungcan.2019.06.017. Epub 2019 Jun 17.

  PMID: 31319977 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Taxes; Immunoenzyme Techniques; Immunohistochemistry

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; Economics; Health Care Economics and Organizations; Immunoassay; Immunologic Techniques; Investigative Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Results Point of Contact

• Title: Gregory Otterson, MD
• Organization: The Ohio State University

Greg.Otterson@osumc.edu

614-293-2887

Study Officials

• Gregory A. Otterson, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 7, 2008
• Study Start: August 14, 2008
• Primary Completion: December 16, 2011
• Study Completion: December 16, 2011
• Last Updated: April 2, 2018
• Results First Posted: June 6, 2016

Record last verified: 2018-03

Locations

US (1)