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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


Phase 2
N/A
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

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Trial Information

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


This is a Phase II study of paclitaxel administered as a 96-hour (4 day) continuous infusion
with a bolus of cisplatin followed by chest radiotherapy for previously untreated patients
with stage III non-small cell lung cancer (NSCLC). The non-small cell lung cancer tissue
obtained prior to the start of treatment will be studied for mutations of the p53 gene. The
goal of this phase II study is to determine the response rate to 4 cycles of infusional
paclitaxel and bolus cisplatin for patients with stage III NSCLC. The response will again
be assessed following completion of 6000 cGy of chest radiotherapy and the patients will
then be followed for survival. The relationship between the presence or absence of a p53
mutation and the sensitivity of the patient's tumors to paclitaxel plus cisplatin and chest
radiation will be studied. In addition, the plasma levels of paclitaxel will be measured,
and the in vitro paclitaxel chemosensitivity of the tumor cells will be determined from as
many patients as possible. This will allow further study of the relationship between p53
status, in vitro drug sensitivity, achievable plasma concentrations of paclitaxel, and
patients' response to therapy.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

960054

NCT ID:

NCT00001499

Start Date:

March 1996

Completion Date:

June 2000

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Carcinoma
  • Combination Chemotherapy
  • Combined Modality Therapy
  • Infusion
  • Intravenous
  • Lung Neoplasm
  • Non-Small Cell Lung Cancer
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892