Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed Description
-----------------
OBJECTIVES: I. Determine whether aminocamptothecin colloidal dispersion (AC/CD) administered as a 120 hour weekly infusion is an effective treatment for advanced non-small cell lung cancer. II. Observe any toxicities associated with this treatment in this patient population. OUTLINE: Patients receive a 120 hour continuous infusion of aminocamptothecin colloidal dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.

Official Title
-----------------
Phase II Trial of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) 120-Hour Continuous Intravenous Infusion in Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: aminocamptothecin colloidal dispersion


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed measurable stage IIIB or IV non-small cell lung cancer No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3500/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Calcium and electrolytes normal Other: No other malignancy within past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix Not pregnant or nursing No active infections or other serious medical conditions PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy No prior radiotherapy to site(s) of measurable disease Surgery: At least 3 weeks since any prior surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aminocamptothecin colloidal dispersion|120 hour continuous infusion of aminocamptothecin colloidal dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. Patients are followed every 3 months.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer. |  | 120 hour continuous infusion once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer