Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Randomized Study of Nab-paclitaxel With Gemcitabine at Two Different Dose Combinations to Determine Efficacy in Patients With Advanced Non- Squamous Non-small Cell Lung Cancer (NSCLC).
Verified date | October 2017 |
Source | West Virginia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2023 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 ß-hCG pregnancy test at screening for patients of childbearing potential Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | West Virginia University Hospitals - Mary Babb Randolph Cancer Center | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
West Virginia University | Celgene Corporation |
United States,
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. Epub 2005 Feb 22. — View Citation
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. — View Citation
Jiang J, Liang X, Zhou X, Huang R, Chu Z, Zhan Q. Non-platinum doublets were as effective as platinum-based doublets for chemotherapy-naïve 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
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