Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer

NCT00001499 | Completed Phase 2

• 2 other identifiers: 96005496-C-0054
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

2-Drug Combination Chemotherapy Followed by Radiotherapy. Paclitaxel, TAX, NSC-125973; Cisplatin, CDDP, NSC-119875; followed by chest irradiation using 4-15 MV photons.

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Keywords

Carcinoma; Combination Chemotherapy; Combined Modality Therapy; Infusion; Intravenous; Lung Neoplasm; Non-Small Cell Lung Cancer

Interventions

paclitaxel DRUG

cisplatin DRUG

chest radiotherapy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer of the following histologies: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, No mixed small/non-small cell carcinoma with predominant small cell component. Unresectable stage IIIA/B disease confined to thorax including: Microscopic disease involvement following attempted surgery and limited to anatomic areas corresponding to stage III disease (N2-3, T3-4). Surgically treated stage I/II disease with histologic or cytologic proof of relapse and limited to anatomic areas corresponding to stage III disease (N2-3, T3-4). T3, N0 tumor extending directly to the chest wall considered resectable and not eligible. No stage IIIB disease with pleural effusion visible on chest x-ray unless related to a previous thoracotomy. No typical carcinoid or mesothelioma. Measurable disease preferred but not required. PRIOR/CONCURRENT THERAPY: No prior chemotherapy or thoracic radiotherapy. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: ECOG 0-2. Hematopoietic: AGC greater than 2,000. Platelets greater than 100,000. Hepatic: Bilirubin no greater than 1.5 mg/dL. Renal: Creatinine no greater than 1.5 mg/dL. Cardiovascular: No symptomatic heart disease including: Less than fully compensated congestive cardiac failure, Significant arrhythmias e.g.: Greater than first-degree heart block, Uncontrolled and symptomatic atrial dysrhythmia except sinus, bradycardia or sustained ventricular tachycardia, Myocardial infarction within 3 months. Pulmonary: No major uncontrolled active infection (unless due to obstructed bronchus). OTHER: No major active psychiatric problem requiring hospitalization or psychotropic medication such as phenothiazines. No prior second malignancy within 5 years except: nonmelanomatous skin cancer, In situ carcinoma of the cervix. No pregnant or nursing women.

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 (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Perez CA, Pajak TF, Rubin P, Simpson JR, Mohiuddin M, Brady LW, Perez-Tamayo R, Rotman M. Long-term observations of the patterns of failure in patients with unresectable non-oat cell carcinoma of the lung treated with definitive radiotherapy. Report by the Radiation Therapy Oncology Group. Cancer. 1987 Jun 1;59(11):1874-81. doi: 10.1002/1097-0142(19870601)59:113.0.co;2-z.

  PMID: 3032394 BACKGROUND

• Cox JD, Azarnia N, Byhardt RW, Shin KH, Emami B, Pajak TF. A randomized phase I/II trial of hyperfractionated radiation therapy with total doses of 60.0 Gy to 79.2 Gy: possible survival benefit with greater than or equal to 69.6 Gy in favorable patients with Radiation Therapy Oncology Group stage III non-small-cell lung carcinoma: report of Radiation Therapy Oncology Group 83-11. J Clin Oncol. 1990 Sep;8(9):1543-55. doi: 10.1200/JCO.1990.8.9.1543.

  PMID: 2167952 BACKGROUND

• Dillman RO, Seagren SL, Propert KJ, Guerra J, Eaton WL, Perry MC, Carey RW, Frei EF 3rd, Green MR. A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in stage III non-small-cell lung cancer. N Engl J Med. 1990 Oct 4;323(14):940-5. doi: 10.1056/NEJM199010043231403.

  PMID: 2169587 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Carcinoma

Interventions

Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: March 1, 1996
• Study Completion: June 1, 2000
• Last Updated: March 4, 2008

Record last verified: 2000-03

Locations

US (1)