Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer

NCT02590003 | Terminated Phase 2 Results DMC

• 1 other identifier: 1403013529
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll elderly patients with advanced non-small cell lung cancer who are at high risk of developing chemotherapy toxicity (side effects). Patients will receive treatment with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity will be compared in the two treatment groups to determine the best treatment strategy for this group of patients.

Conditions

Carcinoma, Non-small Cell Lung

Outcome Measures

Primary Outcomes (1)

• Treatment Failure-free Survival

  90 days

Secondary Outcomes (7)

• Overall Response Rate

  start of treatment to disease progression/recurrence, up to 12 months

• Progression-free Survival

  start of treatment to disease progression, up to 12 months

• Overall Survival

  Up to 12 months

• Grade 3-5 Adverse Events

  Up to week 13

• Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)

  baseline

Study Arms (2)

Platinum-based doublet chemotherapy

EXPERIMENTAL

* Carboplatin AUC 5 30 minute infusion IV on day 1 * Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle

Drug: Carboplatin; Drug: Nab-paclitaxel

Single agent chemotherapy

ACTIVE COMPARATOR

-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle

Drug: Nab-paclitaxel

Interventions

Carboplatin DRUG

Platinum-based doublet chemotherapy

Nab-paclitaxel DRUG

Platinum-based doublet chemotherapy; Single agent chemotherapy

Eligibility Criteria

• Age: 71 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient able and willing to comply with study procedures as per protocol, including the geriatric assessment at the time of study enrollment.
• Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.
• Patients must have histological or cytological confirmed primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous, or unspecified). Disease must be stage IV Non-Small Cell Lung Cancer (NSCLC). Disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation. Primary or metastatic site for biopsy is allowed
• Patients may have measurable or non-measurable disease documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease. Measurable disease must be assessed within 30 days prior to registration per response evaluation criteria in solid tumors (RECIST) v1.1. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non- measurable disease must be assessed within 30 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form.
• Prior chemotherapy for curative intent is permitted providing the cytotoxic chemotherapy was completed ≥12 months prior to enrollment. Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 30 days prior to registration. Patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day. Any radiation therapy completed prior to chemotherapy, except gamma-knife radiosurgery, 1 week prior to chemotherapy.
• Age \>70 years of age at time of signing of the informed consent form.
• Life expectancy of greater than 12 weeks.
• ECOG performance status 0-2 (See Appendix A)
• Patients must have a comprehensive geriatric assessment and chemotherapy toxicity assessment score between 7-17 (See Appendix B, D)
• Patients must have normal organ and marrow function as defined below:
• Leukocytes \>3,000/mcL
• ANC \> 1,500 cells/mm3Hemoglobin \> 9.0g/dL
• Platelets \>100,000 cells/mm3
• Total bilirubin \< 1.5 mg/dL (unless there is a known history of Gilberts Syndrome).
• AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal

You may not qualify if:

• Patients who have had palliative chemotherapy prior to entering the study \<12 months from enrollment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients may not be receiving any other investigational agents or have received immunotherapy.
• Known EGFR or ALK mutated disease (molecular testing not required prior to study entry)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, or nab-paclitaxel.
• 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.
• Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0)
• Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 2 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; 130-nm albumin-bound paclitaxel

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)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Rogerio C. Lilenbaum, MD, Professor of Medicine (Medical Oncology); Chief Medical Officer of Smilow
• Organization: Yale University

rogerio.lilenbaum@yale.edu

(203) 200-5864

Study Officials

• Rogerio Lilenbaum, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: October 12, 2015
• First Posted: October 28, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 28, 2018
• Results First Posted: February 28, 2018

Record last verified: 2018-01

Locations

US (1)