Lung Cancer Clinical Trial

Paclitaxel and Hyperthermic Perfusion in Treating Patients With Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Heating paclitaxel to several degrees above body temperature and infusing it to the affected area around the tumor may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel given by hyperthermic perfusion in treating patients with lung cancer or lung metastases that cannot be removed by surgery.

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Full Description

OBJECTIVES:

Determine the maximum tolerated dose and phase II dose of paclitaxel administered via hyperthermic retrograde isolated lung perfusion in patients with unresectable pulmonary malignancies.
Determine the nature of the toxic effects of this regimen in this patient population.
Evaluate the pharmacokinetic profile of this regimen in these patients.
Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study of paclitaxel.

Patients undergo posterolateral thoracotomy or median sternotomy. Patients receive paclitaxel over 90 minutes administered via hyperthermic retrograde isolated lung perfusion. The entire surgery lasts approximately 4 hours.

Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 and 2 months. Patients with responding disease continue to be followed every 3 months.

PROJECTED ACCRUAL: A maximum of 31 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed unresectable primary lung cancer or pulmonary metastases that are unresectable on the basis of technical considerations or are sufficiently numerous that recurrent, potentially inoperable disease is highly probable

Bilateral metastases allowed
Unresectable bronchoalveolar carcinomas allowed
Previously treated primary lung cancer allowed
Disease outside confines of thorax allowed, provided bulk of disease in the chest is clearly the greatest threat to survival and/or extrathoracic disease is controlled
No potentially treatable pulmonary metastases from lymphomas or germ cell tumors
No biopsy proven interstitial fibrosis, radiation induced pneumonitis, or evidence of significant pulmonary hypertension by history, radiologic, echocardiographic, or catheterization studies

No active intracranial or leptomeningeal metastases

Prior resection or radiotherapy for intracranial metastases allowed if the following criteria are met:

No active disease on 2 MRIs done one month apart
No requirement for anticonvulsant medications or steroids

Adequate pulmonary reserve to tolerate pneumonectomy:

Oxygen consumption greater than 50% predicted AND
FEV1 and DLCO greater than 80% predicted OR
FEV1 or DLCO less than 80% predicted allowed if postoperative FEV1 and DLCO is at least 40% predicted on the basis of split function V/Q scan
Prior radiotherapy to chest allowed provided 6 months have elapsed since completion of treatment and no history of, nor current evidence of, interstitial lung disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

More than 3 months

Hematopoietic:

Platelet count greater than 100,000/mm^3
Hemoglobin greater than 10 g/dL
WBC greater than 3,500/mm^3

Hepatic:

PT/PTT normal
Bilirubin less than 1.5 times upper limit of normal (ULN)
AST/ALT less than 1.5 times ULN

Renal:

Creatinine less than 1.6 mg/dL

Cardiovascular:

Fixed defects on thallium scanning with ejection fraction greater than 40% allowed
Reversible or ischemic defects allowed only after cardiology clearance

Pulmonary:

See Disease Characteristics
Resting oxygen saturation greater than 90%
pCO_2 less than 45 mmHg by arterial blood gas

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infections
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

More than 30 days since prior biologic therapy for this malignancy

Chemotherapy:

More than 30 days since prior chemotherapy for this malignancy
Prior paclitaxel allowed
No prior bleomycin, nitrosoureas, or busulfan

Endocrine therapy:

See Disease Characteristics

Radiotherapy:

See Disease Characteristics

Surgery:

See Disease Characteristics
Prior thoracic surgery allowed

Study is for people with:

Lung Cancer

Phase:

Phase 1

Study ID:

NCT00020007

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda Maryland, 20892, United States
NCI - Center for Cancer Research
Bethesda Maryland, 20892, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Study ID:

NCT00020007

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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