RECRUITINGPhase 2INTERVENTIONAL
Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
Phase II Study of Dose Attenuated Chemotherapy in Patients With Lung Cancer and Age > 70 and/or Comorbidities
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Must have diagnosed by tissue sample (biopsy-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.
- History of treated or untreated asymptomatic cancer that has spread to the brain are eligible, provided they meet all of the following criteria:
- No ongoing requirement for corticosteroids as therapy for CNS disease
- No stereotactic radiation or whole-brain radiation within 7 days prior to treatment initiation
- Stable doses of anti-seizure medications are allowed if CNS disease has been treated and is stable. Treatment of CNS disease can include surgery, radiation or response to previous cancer treatment that works throughout the body (like chemotherapy).
- May have received prior therapy for lung cancer. There is no limit on the number of prior therapies.
- Age \> 18 years
- You should be able to carry out daily activities with 0 level of ability (ECOG 0)-3
- Ability to understand and willingness to sign a written informed and HIPAA consent documents.
- Females of child-bearing potential must be willing to use an effective method of contraception for the course of the study through at least 6 months after the last dose of study medication.
- Patients with known HIV infection and are receiving combination antiretroviral therapy with a viral load \<400 copies per mL at screening or CD4+ T-cell count \> 350 cell per μL at screening and no history of AIDS-defining opportunistic infection \< 12 months before first dose of study drug are eligible.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 RECIST criteria 1.1.
* History of treated or untreated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
* No ongoing requirement for corticosteroids as therapy for CNS disease
* No stereotactic radiation or whole-brain radiation within 7 days prior to treatment initiation
* Stable doses of anti-seizure medications are allowed if CNS disease has been treated and is stable. Treatment of CNS disease can include surgery, radiation or response to prior systemic therapy.
* May have received prior therapy for lung cancer. There is no limit on the number of prior therapies.
* Age \> 18 years
* ECOG performance status of 0-3
* Ability to understand and willingness to sign a written informed and HIPAA consent documents.
* Females of child-bearing potential must be willing to use an effective method of contraception for the course of the study through at least 6 months after the last dose of study medication.
* Patients with known HIV infection and are receiving combination antiretroviral therapy with a viral load \<400 copies per mL at screening or CD4+ T-cell count \> 350 cell per μL at screening and no history of AIDS-defining opportunistic infection \< 12 months before first dose of study drug are eligible.
* Males who are fertile and who have partners who are Women of Child-bearing Potential (WOCBP) must agree to use effective method(s) of contraception as outlined in section 4.4 from the start of trial treatment, for the course of the study and 6 months after the last dose of study treatment.
Exclusion Criteria:
* 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.
* Undergone major surgery within 28 days prior to first dose of study treatment. The patient has elective or planned major surgery to be performed during the course of the clinical trial.
* Have not recovered from adverse events due to anticancer agents administered previously except neuropathy, alopecia or endocrinopathies that can be treated with replacement therapy. Physician's discretion is allowed to decide which unresolved adverse events from previous therapy prohibit patient participation in this study.
* Uncontrolled illness including, but not limited to, ongoing or active infection (other than chronic viral infections that are controlled, e.g. HIV, as described above), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (uncontrolled), cirrhosis, or psychiatric illness/ social situations that would limit compliance with the study requirements.
* Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Indwelling catheters (e.g., PleurX®) are allowed.
* Corrected serum Ca \> 12 mg/dl.
* Patients who are receiving hypocalcemic therapies (e.g. denosumab, bisphosphonates) who achieve appropriate serum calcium levels are eligible.
* Pregnant or breast feeding.
Treatments Being Tested
DRUG
Carboplatin
Standard of care chemotherapy regimen
DRUG
Pemetrexed
Standard of care chemotherapy regimen
DRUG
Paclitaxel
Standard of care chemotherapy regimen
DRUG
Nab paclitaxel
Standard of care chemotherapy regimen
DRUG
Docetaxel
Standard of care chemotherapy regimen
DRUG
Gemcitabine
Standard of care chemotherapy regimen
DRUG
Etoposide
Standard of care chemotherapy regimen
DRUG
Irinotecan
Standard of care chemotherapy regimen
DRUG
Topotecan
Standard of care chemotherapy regimen
DRUG
Lurbinectedin
Standard of care chemotherapy regimen
Locations (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States