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Cisplatin in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer or Lung Metastasis

Information source: Roswell Park Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Malignant Neoplasm in the Lung; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Adult Soft Tissue Sarcoma; Stage IV Non-Small Cell Lung Cancer

Intervention: Cisplatin (Drug); Pharmacological Study (Other)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Roswell Park Cancer Institute

Official(s) and/or principal investigator(s):
Todd Demmy, Principal Investigator, Affiliation: Roswell Park Cancer Institute

Summary

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.

Clinical Details

Official title: Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Acute toxicity assessed using CTCAE version 4.0

Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT

Reversibility of all toxicities from this approach.

Secondary outcome:

Lung, systemic, and pulmonary artery concentrations of cisplatin

Pulmonary function test with diffusion capacity

Split lung function test

Detailed description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose and dose-limiting toxicities of cisplatin when delivered selectively by isolated lung suffusion to patients with any biopsy or cytologically proven resectable or unresectable primary or secondary malignancy in the lung. SECONDARY OBJECTIVES: I. To assess lung tissue levels of cisplatin after isolated lung suffusion as a function of the dose delivered. II. To evaluate systemic and pulmonary artery concentrations of cisplatin during isolated lung suffusion. OUTLINE: This is a dose-escalation study. Patients receive cisplatin intra-arterially via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks if indicated for patients with sarcoma undergoing surgery after cisplatin), patients receive standard chemotherapy regimen.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 disease 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; generally, bulky metastatic disease causes performance impairment that would exclude the patient from being eligible because of the pulmonary and other requirements; 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 exclusion

criteria 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) Exclusion Criteria:

- Uncontrolled intercurrent disease

- Prior chemotherapy for proven metastatic disease within 4 weeks

- Evidence of pulmonary toxicity from previous or ongoing chemotherapy

- Creatinine > 1. 5 mg/dL

- Liver enzymes > 2 times upper normal

- Uncontrolled congestive heart failure (in judgment of the PI)

- Optional: ejection fraction < 40% for clinical evidence of insufficient cardiac

reserve (multi gated acquisition scan [MUGA] or echocardiogram [ECHO] will be done only if indicated in the judgment of the PI)

- Myocardial infarction or angina within past 6 months

- Contraindications to anticoagulation

- Hydration intolerance (e. g., uncontrolled congestive heart failure [CHF])

- Human immunodeficiency virus positive (HIV+) on antiretroviral therapy

- Pregnant or lactating

- Diffuse pulmonary fibrosis involving over 25% of the total lung parenchyma

- Previous radiation for thorax

- Metastatic sarcoma to lung that is not able to have tumors resected thoracoscopically

- Prior lung removal in the affected lung (would have decreased lung volume)

Locations and Contacts

Roswell Park Cancer Institute, Buffalo, New York 14263, United States
Additional Information

Starting date: May 2006
Last updated: June 9, 2015

Page last updated: August 23, 2015

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