Study of Lung Chemotherapy in the Treatment of Advanced Lung Cancer and Metastatic Sarcoma
This study has suspended participant recruitment.
Sponsor:
Roswell Park Cancer Institute
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
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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