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

NCT01014598 | Completed Phase 1

• 2 other identifiers: I 70005NCI-2009-01604
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Acute toxicity assessed using CTCAE version 4.0

  Within 7 days from lung infusion

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

  DLT is defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A grade 3 or above adverse event shall be considered a DLT in this study if attributed to the isolated lung suffusion cisplatin dose.

  Within 30 days of the procedure

• Reversibility of all toxicities from this approach.

  Up to 90 days from the start of lung infusion therapy

Secondary Outcomes (3)

• Lung, systemic, and pulmonary artery concentrations of cisplatin

  Before pulmonary artery release, at 15 minutes, and 1 hour

• Pulmonary function test with diffusion capacity

  Up to 30 days post-treatment

• Split lung function test

  Up to 30 days post-treatment

Study Arms (1)

Treatment (cisplatin)

EXPERIMENTAL

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.

Drug: Cisplatin; Other: Pharmacological Study

Interventions

Cisplatin DRUG

Given intra-arterially via isolated lung suffusion

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Treatment (cisplatin)

Pharmacological Study OTHER

Correlative studies

Treatment (cisplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Sarcoma

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals

Study Officials

• Chukwumere Nwogu

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: December 4, 2007
• Primary Completion: October 23, 2013
• Study Completion: May 1, 2017
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)