Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.

NCT02405910 | Withdrawn Phase 2 DMC

• 1 other identifier: WVU020514
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine, at two different dose combinations as first line therapy in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC).

Conditions

Non-small Cell Lung Cancer

Keywords

advanced; non-squamous; first line therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  To assess the progression-free survival (PFS) on patients with nab-paclitaxel and Gemcitabine at two different dose combinations and to compare the PFS to the historical data

  From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.

Secondary Outcomes (1)

• To explore differences in progression free survival (PFS) between two dose combinations of nab-paclitaxel with Gemcitabine in patients with advanced NSCLC.

  From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.

Study Arms (2)

A - Nab-paclitaxel 100mg + Gemcitabine 1250mg

EXPERIMENTAL

Nab-paclitaxel 100 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on days 1, 8 and 15 of a 21 day cycle. On days 1 and 8 of each cycle, nab-paclitaxel administration will be followed by the administration of gemcitabine 1250 mg/m2 as a 30 minute infusion (maximum 40 minutes).

Drug: Nab-paclitaxel; Drug: Gemcitabine

B - Nab-paclitaxel 125mg + Gemcitabine 1000mg

EXPERIMENTAL

Nab-paclitaxel 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on days 1, 8 and 15 of a 28 day cycle. Each nab-paclitaxel administration will be followed by the administration of gemcitabine 1000 mg/m2 as a 30 minute infusion (maximum 40 minutes) on days 1, 8 and 15. Treatments will be repeated until progression or intolerance.

Drug: Nab-paclitaxel; Drug: Gemcitabine

Interventions

Nab-paclitaxel DRUG

Also known as: Abraxane, ABI-007

A - Nab-paclitaxel 100mg + Gemcitabine 1250mg; B - Nab-paclitaxel 125mg + Gemcitabine 1000mg

Gemcitabine DRUG

Also known as: Gemzar, LY-188011

A - Nab-paclitaxel 100mg + Gemcitabine 1250mg; B - Nab-paclitaxel 125mg + Gemcitabine 1000mg

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven newly diagnosed stage IV or stage IIIB non-squamous Non-small Cell Lung Cancer (NSCLC) - Recurrent advanced NSCLC will be allowed if they have never received chemotherapy for metastatic disease. - Prior adjuvant chemotherapy will be allowed, if recurrence occurred ≥ 6 months after last treatment
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Washout period of 4 weeks for chemo/radiation/experimental agents
• Resolution of all toxicities to \< grade 2 prior to starting treatment (excluding alopecia)
• Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE)
• Adequate hepatic, renal, and bone marrow functions
• Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
• Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential

You may not qualify if:

• Patient with New York Heart Association class III or IV heart failure
• Women of child bearing potential (WOCBP) are not currently pregnant or breast-feeding
• Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma
• Previous anaphylactic or severe allergic reaction to paclitaxel and/or docetaxel will be excluded
• Grade ≥2 peripheral neuropathy at baseline assessment from any cause
• Symptomatic brain metastases will be excluded. Treated Brain metastases will be allowed that are neurologically stable.
• Patients with adenocarcinoma with activating EGFR mutation (exon 19 deletions / insertions, exon 21 point mutations) or EML4-ALK translocation are excluded unless they are ineligible for epidermal growth factor receptor (EGFR) or ALK targeting agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• West Virginia University: lead
• Celgene Corporation: collaborator

Study Sites (1)

West Virginia University Hospitals - Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (3)

• D'Addario G, Pintilie M, Leighl NB, Feld R, Cerny T, Shepherd FA. Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature. J Clin Oncol. 2005 May 1;23(13):2926-36. doi: 10.1200/JCO.2005.03.045. Epub 2005 Feb 22.

  PMID: 15728229 BACKGROUND

• Jiang J, Liang X, Zhou X, Huang R, Chu Z, Zhan Q. Non-platinum doublets were as effective as platinum-based doublets for chemotherapy-naive advanced non-small-cell lung cancer in the era of third-generation agents. J Cancer Res Clin Oncol. 2013 Jan;139(1):25-38. doi: 10.1007/s00432-012-1294-z. Epub 2012 Aug 5.

  PMID: 22864816 BACKGROUND

• Davidoff AJ, Tang M, Seal B, Edelman MJ. Chemotherapy and survival benefit in elderly patients with advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2191-7. doi: 10.1200/JCO.2009.25.4052. Epub 2010 Mar 29.

  PMID: 20351329 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Manish Monga, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 1, 2015
• Study Start: March 15, 2015
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2023
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

US (1)