Cisplatin in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer or Lung Metastasis
This phase I trial studies the side effects and best dose of cisplatin in treating patients with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they started to the lung (metastasis). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cisplatin directly into the arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 25, 2022 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Roswell Park Cancer Institute
- Interventions being studied
- Drug: Cisplatin; Other: Pharmacological Study
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Any biopsy or cytologically proven resectable or unresectable primary or secondary (metastatic) malignancy in the lung; this is defined as
- Tumors whose only remaining residual deposits are confined to the lungs OR
- Oligometastatic tumors with \> 80% of measurable tumor volume in the target lung In both of the above situations, no clinical evidence of central nervous system (CNS) metastases can exist; oligometastatic disease is difficult to define but would, as a guideline, have only 1-4 loci of disease established in 1-2 organ systems outside the affected lung; exceptions to these guidelines can occur, particularly in cases where sites of metastatic disease are equivocal or so minute that it would not exceed 20% of tumor volume
- Unresectable stage IV non-small cell lung cancer (NSCLC)
- Unresectable stage IIIB NSCLC
- Resectable metastatic sarcoma to lung (thoracoscopically resectable)
- Other malignancies that meet the criteria
- Eastern Cooperative Oncology Group performance status 0-1
- No oxygen needs (oxygen use per standard established criteria for oxygen requirements)
- Modified Borg dyspnea scale \< 5
- Six minute walk \>= 50% of the expected distance; this will not be used as
- if due to a reason other than respiratory per judgment of physician e.g., pain
- Ambulatory and resting oxygen (O2) saturation \> 88%
- PPO (predicted post operative)\
- forced expiratory volume in one second (FEV1) \>= 50% predicted
- PPO values should be calculated for each patient
- PPO \
- diffusing capacity of the lung for carbon monoxide (DLCO) \>= 50% predicted
- PPO values should be calculated for each patient
- PPO \
- vital capacity \>= 50% predicted
- PPO values should be calculated for each patient
- Granulocytes \> 1,500 ul
- Platelets \>= 100,000 ul
- Patients must sign a study-specific consent form prior to registration
- Tumor anatomy must allow the isolated lung suffusion in the judgment of the principal investigator (PI)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Roswell Park Cancer InstituteBuffalo, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 25, 2022. Always confirm current availability with the study team.