Phase II Study of Dose Attenuated Chemotherapy in Patients With Lung Cancer and Age > 70 and/or Comorbidities
Fox Chase Cancer Center
Summary
This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities.
Description
This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities. The investigator will indicate the rationale(s) for dose modification based on the subgroups of patients listed in the protocol. Patients may fit into multiple subgroups and this is accounted for in the prospectively defined dose reduction level as listed in the protocol. Prespecified doses by chemotherapeutic agent and dose level adjustment based on patient characteristics an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Must have histologically or cytologically confirmed stage IV (AJCC version 8) lung cancer (small cell or non-small cell). Patients with stage III disease who are not felt to be candidates for definitive therapy are also eligible. * Must fit into at least one of the subgroups of patients as defined in section 3.3. * Patients must have planned therapy with a regimen that includes at least one cytotoxic agent as listed in Table 1 (e.g. platinum, taxane, anti-metabolite, vinca alkaloid, podophylotoxin, camptothecin, lurbinectidin etc). * Must have measurable disease as per R…
Interventions
- DrugCarboplatin
Standard of care chemotherapy regimen
- DrugPemetrexed
Standard of care chemotherapy regimen
- DrugPaclitaxel
Standard of care chemotherapy regimen
- DrugNab paclitaxel
Standard of care chemotherapy regimen
- DrugDocetaxel
Standard of care chemotherapy regimen
- DrugGemcitabine
Standard of care chemotherapy regimen
- DrugEtoposide
Standard of care chemotherapy regimen
Location
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania