LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer

NCT02328105 | Completed Phase 2 Results DMC

• 2 other identifiers: LCI-LUN-ABR-00100010224
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

ABRAXANE, based on results from prior studies, is a promising drug in squamous cell carcinoma of the lung. This study will help to explore the combination of ABRAXANE and carboplatin more thoroughly in the subgroup of patients who had the best response in prior studies as well as determine whether there are any biomarkers which can predict for response.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Response

  The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by \>= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.

  Up to a planned 18 weeks

Secondary Outcomes (5)

• Number of Subjects With Stable Disease or Response

  18 weeks

• Progression Free Survival

  From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 3 years

• Overall Survival

  From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years

• Duration of Response

  From date of response to date of progression/death, or censored as described above; assessed for approximately 3 years.

• Duration of Disease Control

  From date of treatment start to date of progression, or censored as described above; assessed for approximately 3 years

Study Arms (1)

Carboplatin + Abraxane

EXPERIMENTAL

Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment

Drug: Carboplatin; Drug: Abraxane

Interventions

Carboplatin DRUG

Dosing: AUC = 6; on Day 1

Carboplatin + Abraxane

Abraxane DRUG

100 mg/m\^2; Days 1, 8, 15

Also known as: nab-paclitaxel

Carboplatin + Abraxane

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed stage IV non-small cell lung cancer with predominantly squamous histology
• No prior systemic treatment for metastatic disease. Patients who have received prior adjuvant chemotherapy for early-stage lung cancer are eligible if at least 12 months have elapsed between the date of final chemotherapy administration and the date of consent
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or as \>10 mm with CT scan, MRI, or calipers by clinical exam
• Biopsy accessible disease
• Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Definitive radiation therapy must have been completed \>4 weeks prior to the date the informed consent is signed
• Age \>18 years
• ECOG performance status less than or equal to 1
• If patient has brain metastasis, the disease must be stable (treated and/or asymptomatic) for at least 4 weeks prior to first dose of study treatment
• Bilirubin \< 1.5 mg/dL
• Adequate liver function: AST and ALT \<= 2.5x upper limit of normal, alkaline phosphatase \<= 2.5x upper limit of normal, unless bone metastasis is present (\< 5x upper limit of normal) in the absence of liver metastasis
• Adequate bone marrow function: Platelets \>100,000 cells/mm3, Hemoglobin \> 9.0g/dL and ANC \> 1,500 cells/mm3
• Adequate renal function with creatinine \<1.5 mg/dL is recommended
• Females of childbearing potential and sexually active males must use an effective contraception method during treatment and for six months after completing treatment
• Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential
• Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE version 4.0)

You may not qualify if:

• Received prior systemic therapy for metastatic disease
• Received limited field radiation for palliation \<= 2 weeks prior to starting study treatment and/or from whom \>= 30% bone marrow was irradiated
• Receiving any other investigational agents
• Known hypersensitivity to either carboplatin or ABRAXANE
• Uncontrolled and current 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
• Pregnant or breast feeding
• Other active malignancies
• Neuropathy greater than or equal to grade 2

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Celgene: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chair of Biostatistics Department
• Organization: Levine Cancer Institute

james.symanowski@atriumhealth.org

9804422371

Study Officials

• Kathryn Mileham, M.D.

  Wake Forest University Health Sciences

  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

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: June 15, 2017
• Study Completion: December 6, 2019
• Last Updated: August 9, 2022
• Results First Posted: July 11, 2018

Record last verified: 2021-05

Locations

US (1)