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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer.

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Nathan Levitan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU1597

NCT ID:

NCT00003154

Start Date:

January 1998

Completion Date:

June 2001

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065