Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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 RECIST criteria 1.1.
Disqualifiers
Patients receiving only a targeted agent (e.g. TKI, sotorasib etc.) or immunotherapy without a cytotoxic agent.
Patients currently receiving investigational agents for cancer.
Patients with ECOG PS 3 and hepatic or renal dysfunction.
Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.
Trial design
Treatments tested in this trial
- Carboplatin
- Pemetrexed
- Paclitaxel
- Nab paclitaxel
- Docetaxel
- Gemcitabine
- Etoposide
- Irinotecan
- Topotecan
- Lurbinectedin
Treatment groups
280 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov