Study of Lung Chemotherapy in the Treatment of Advanced Lung Cancer and Metastatic Sarcoma

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01014598
First received: November 16, 2009
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

This is a phase I, open label, non-randomized single institution study to determine the maximum tolerated dose of cisplatin delivered selectively by isolated lung infusion (suffusion) to patients with unresectable lung cancer and metastatic sarcoma.


Condition Intervention Phase
Lung Cancer
Sarcoma
Drug: Cisplatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Targeted Lung Chemotherapy in the Treatment of Unresectable or Advanced Stage Lung Cancer and Metastatic Sarcoma

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • To determine the maximum tolerated dose and dose-limiting toxicities of cisplatin when delivered selectively by isolated lung suffusion to patients with unresectable lung cancer or resectable metastatic sarcoma to lung [ Time Frame: 90 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess lung tissue levels of cisplatin after isolated lung suffusion as a function of the dose delivered. [ Time Frame: 90 days after tissue is received ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: December 2007
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin
Dose escalation of Cisplatin
Drug: Cisplatin
Given Isolated Lung suffusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy or cytologically proven unresectable stage IV, or unresectable stage IIIB non small cell lung cancer (including recurrent lung cancer) or metastatic sarcoma to the lung. This is defined as oligometastatic disease with > 80 % of measurable tumor volume in the target lung and no clinical evidence of CNS metastases. Oligometastatic disease is difficult to define but would 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 exceed 20% of tumor volume. 1)Unresectable Stage IV NSCLC,2) Unresectable Stage 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 IIIB NSCLC, 3)Resectable metastatic sarcoma to lung (Thoracoscopically resectable)
  • ECOG status 0-1

Pulmonary Requirements:

  • No oxygen needs
  • Modified Borg Dyspnea scale<5
  • Six minute walk Greater than or equal to 50% of the expected distance
  • Ambulatory and resting oxygen saturation> 88%
  • Predicted Post Operative(PPO) FEV1 greater than or equal to 50% predicted
  • PPO DLCO greater than or equal to 50% predicted
  • PPO Vital capacity greater than or equal to 50% predicted

Laboratory Requirements:

  • Granulocytes > 1500ul
  • Platelets > 100,000ul
  • Must sign study specific consent prior to registration
  • Tumor anatomy must be such that it will allow the isolated lung suffusion in judgment of PI.

Exclusion Criteria:

  • Uncontrolled intercurrent disease
  • Chemotherapy within 8 weeks
  • Prior chemotherapy for proven metastatic disease
  • Evidence of pulmonary toxicity from previous or ongoing chemotherapy

Insufficient organ reserve:

  • Creatinine > 1.5 mg/dl
  • Liver enzymes > 2 times upper normal
  • Uncontrolled congestive heart failure
  • Ejection fraction < 40%
  • Myocardial infarction or angina within past 6 months
  • Contraindications to anticoagulation
  • Hydration intolerance (e.g.congestive heart failure)
  • History of auditory impairment
  • HIV+ on antiretroviral therapy (e.g.tinnitus, sensory-neural hearing loss)
  • 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 will be excluded
  • Prior lung removal in the affected lung (would have decreased lung volume)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014598

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Todd Demmy, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01014598     History of Changes
Other Study ID Numbers: I 70005
Study First Received: November 16, 2009
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
Advanced Stage
Metastatic

Additional relevant MeSH terms:
Lung Neoplasms
Sarcoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013