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A Phase I Study of Targeted Lung Chemotherapy in the Treatment of Unresectable or Advanced Stage Lung Cancer and Metastatic Sarcoma

Phase 1
18 Years
Not Enrolling
Lung Cancer, Sarcoma

Thank you

Trial Information

A Phase I Study of Targeted Lung Chemotherapy in the Treatment of Unresectable or Advanced Stage Lung Cancer and Metastatic Sarcoma

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)

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

90 days after surgery

Safety Issue:


Principal Investigator

Todd Demmy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

I 70005



Start Date:

December 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • Sarcoma
  • Advanced Stage
  • Metastatic
  • Lung Neoplasms
  • Sarcoma



Roswell Park Cancer Institute Buffalo, New York  14263