Study on Reduced Dose Chemotherapy for Lung Cancer Patients with Other Health Conditions

Sponsor: Fox Chase Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05800587

Provider View

This clinical trial is testing a modified chemotherapy treatment plan for lung cancer patients who have additional health issues. The study aims to find out if adjusting the chemotherapy dose can be effective and safe for these patients.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a reduced dose of chemotherapy works and how safe it is for lung cancer patients who also have other health conditions. The study will look at different groups of patients to see how they respond to the adjusted doses of chemotherapy. The treatment plan will be personalized based on each patient's health status and other medical conditions.

Description

This study is designed to test the effectiveness and safety of chemotherapy at reduced doses for lung cancer patients who have other health issues. The study will include patients with stage IV lung cancer or stage III lung cancer who cannot undergo standard treatment. Patients will be grouped based on their specific health conditions, and the chemotherapy dose will be adjusted accordingly. The study will monitor how well the treatment works and any side effects experienced by the patients. The goal is to find a balance between effective cancer treatment and managing other health conditions.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed stage IV lung cancer or stage III lung cancer not suitable for standard treatment.
  • Must fit into at least one specific health condition group as defined in the study.
  • Must be planning to receive a chemotherapy regimen that includes at least one cytotoxic drug.
  • Must have measurable cancer as per standard criteria.
  • Can have a history of treated or untreated brain metastases if stable and not requiring steroids.
  • Can have received previous lung cancer treatments with no limit on the number of prior therapies.
  • Must be 18 years or older.
  • Must have an ECOG performance status of 0 to 3.
  • Must be able to understand and sign consent forms.
  • Women of childbearing potential must use effective contraception during the study and for 6 months after.
  • Patients with controlled HIV infection are eligible.
  • Men with partners who can become pregnant must use effective contraception during the study and for 6 months after.

Exclusion Criteria

  • Patients receiving only targeted therapy or immunotherapy without chemotherapy.
  • Patients currently in other cancer trials.
  • Patients with severe liver or kidney problems and an ECOG status of 3.
  • Patients with gastrointestinal blockages or needing regular IV nutrition.
  • Patients who had major surgery within 28 days before starting the study.
  • Patients who have not recovered from previous cancer treatment side effects, except for certain conditions.
  • Patients with uncontrolled illnesses like active infections, heart failure, or psychiatric issues.
  • Patients with other cancers that could interfere with the study.
  • Patients with leptomeningeal disease.
  • Patients with uncontrolled fluid buildup in the body requiring frequent drainage.
  • Patients with high calcium levels unless controlled by treatment.
  • Pregnant or breastfeeding women.

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