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AzTrials

Lung CancerPhase 2NCT00729612

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

A Phase 2 study testing carboplatin, paclitaxel albumin-stabilized nanoparticle formulation and protein expression analysis in people with Lung Cancer, run by Greg Otterson at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, paclitaxel albumin-stabilized nanoparticle formulation and protein expression analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteUnited States
Study dates
14 Aug 2008to 16 Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Lung Cancer
Being tested
carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, protein expression analysis, immunoenzyme technique, immunohistochemistry staining method
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
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00729612
Study groupRoleWhat they receive
Treatment (nab-paclitaxel, carboplatin)ExperimentalPatients 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.
Receives: Drug: carboplatin; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Genetic: protein expression analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (3)

  1. 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

    Measured: Up to 5 years

  2. Overall Survival

    Will be analyzed using a Kaplan-Meier methods.

    Measured: Up to 5 years

  3. 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

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2008 (estimated)
  2. Study start14 Aug 2008
  3. Primary completion16 Dec 2011
  4. Study completion16 Dec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00729612
Sponsor's protocol ID
OSU-08059
Other IDs
NCI-2011-03196
Status last verified
Mar 2018
First submitted
6 Aug 2008
Last updated
2 Apr 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26123189

  • 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.

    PubMed 31319977

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, paclitaxel albumin-stabilized nanoparticle formulation and protein expression analysis in people with Lung Cancer, run by Greg Otterson at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria. (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00729612, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.

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