RECRUITING

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

Conditions

Lung Cancer Small-cell Lung Cancer Non Small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Phase II Study of Dose Attenuated Chemotherapy in Patients With Lung Cancer and Age > 70 and/or Comorbidities

Quick Facts

Study Start:2023-02-22

Study Completion:2029-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05800587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Ryan Romasko

CONTACT

2678388380

ryan.romasko@fccc.edu

Principal Investigator

Julia Judd, DO

PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

Julia Judd, DO, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-22

Study Completion Date2029-08-01

Study Record Updates

Study Start Date2023-02-22

Study Completion Date2029-08-01

Terms related to this study

Additional Relevant MeSH Terms

Lung Cancer
Small-cell Lung Cancer
Non Small Cell Lung Cancer