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

NCT00020007 | Completed Phase 1

• 2 other identifiers: CDR0000067490NCI-00-C-0019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Cancer; Metastatic Cancer

Keywords

recurrent non-small cell lung cancer; limited stage small cell lung cancer; extensive stage small cell lung cancer; recurrent small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; lung metastases; bronchoalveolar cell lung cancer; pulmonary carcinoid tumor

Interventions

isolated perfusion DRUG

paclitaxel DRUG

hyperthermia treatment PROCEDURE

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Paclitaxel; Diathermy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Hyperthermia, Induced; Therapeutics

Study Officials

• David S. Schrump, MD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: December 1, 1999
• Last Updated: April 29, 2015

Record last verified: 2006-01

Locations

US (2)