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

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729612
• Other study ID #: OSU-08059
• Secondary ID: NCI-2011-03196
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2008
• Last updated: March 6, 2018
• Start date: August 14, 2008
• Est. completion date: December 16, 2011

Study information

• Verified date: March 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• To determine the response rate, in terms of overall response rate (complete response and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who are ineligible for treatment with bevacizumab.

Secondary

• To evaluate safety of this regimen in these patients.

• To describe the overall survival of these patients.

• To describe progression-free survival of these patients.

Tertiary Objectives

• To explore, in a pilot fashion, the activity of this regimen using predictive biomarkers including serum SPARC levels, methylation of SPARC in primary tumor samples and serum, Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA expression profiles.

OUTLINE: 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.

Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND SPARC by immunohistochemistry, and serum miRNA expression profiling.

After completion of study treatment, patients are followed periodically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 16, 2011
• Est. primary completion date: December 16, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• carboplatin

• paclitaxel albumin-stabilized nanoparticle formulation

Genetic:
• protein expression analysis

Other:
• immunoenzyme technique

• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Greg Otterson	Celgene Corporation, National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression Free Survival	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	Up to 5 years
Secondary	Overall Survival	Will be analyzed using a Kaplan-Meier methods.	Up to 5 years
Secondary	Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0	The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics	Up to 5 years

External Links

•   The Jamesline