Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title A Phase II, multicenter, single arm study of the tolerability of weekly nab-paclitaxel as second line treatment for elderly patients with advanced lung cancer
IRB UNC2512
CC 13-028
Hospital Main Campus
Phase Phase 2
Disease Lung
Drug Nab-Paclitaxel
Description
Primary Objective- To evaluate the tolerability of weekly nab-paclitaxel in older adults with advanced lung cancer who have progressed on at least 1 prior regimen after 6 cycles or 3 weeks after discontinuation of treatment, for those who come off treatment earlier.
- To estimate overall survival (OS)
- To estimate progression-free survival (PFS)
- To estimate the response rate (RR)
- To explore baseline components of the GA as predictors of chemotherapy tolerance and overall survival
- To explore the use of p16 measurements in the elderly as predictors of chemotherapy tolerance and overall survival
- To explore the impact of weekly nab-paclitaxel treatment on quality of life, as measured by LCSS and FACT-L
Inclusion Criteria
- Signed, written informed consent
- Male or female patient
- ≥ 70 years of age
- Diagnosis of NSCLC, histologically or cytologically confirmed
- International Association for the Study of Lung Cancer (IASLC) Version 7, Stage IV disease; or recurrence after prior surgery or radiotherapy
- Progression following one line of prior chemotherapy consisting of:
- a platinum agent plus a standard cytotoxic partner agent other than a taxane (typically pemetrexed, gemcitabine, or vinorelbine);
- OR a single agent, non-cytotoxic regimen (such as erlotinib or crizotinib) if the patient has a molecular change that the non-cytotoxic regimen would be expected to be efficacious for (ex. EGFR mutation for erlotinib and EML4/ALK or ROS1 for crizotinib)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2; see Appendices, Section 11.1
- Adequate organ and bone marrow function as defined by:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Hemoglobin ≥ 9 g/dL (it is acceptable to reach this through transfusion)
- Platelets > 100,000 cells/mm^3
- Creatinine ≤ 1.5mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN
- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN
- Recovered from all reversible toxicities related to their previous treatment (other than alopecia) to ≤ grade 1 or baseline
- Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
- Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry, for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care.
- Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential
- Patients with brain metastases may participate if they have undergone appropriate treatment for the lesion(s), are at least two weeks post treatment without evidence for post-treatment progression, have no significant neurologic symptoms, and no longer require steroids for the reason of brain metastases. Patients with symptoms suggestive of CNS metastases should be evaluated with imaging prior to study participation.
Exclusion Criteria
- Prior taxane therapy for any indication
- Less than 3 weeks elapsed since prior exposure to chemotherapy
- Pre-existing neuropathy greater than grade 1
- Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion.
- Concomitant anticancer therapy, immunotherapy, or radiation therapy (no radiation within prior 4 weeks)
- Have received treatment within the last 30 days prior to study entry with any drug that has not received regulatory approval for an indication at the time of study entry
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded due to the potential for teratogenic or abortifacient effects of nab-paclitaxel. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued prior to participation of the mother on study.
- Known hypersensitivity to protein bound paclitaxel
- Any other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol
