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Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer


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

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Trial Information

Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer


OBJECTIVES:

- Determine the antitumor activity and toxicities of irinotecan and paclitaxel in
patients with advanced non-small cell lung cancer.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV
over 30 minutes. Treatment continues weekly for 2 weeks followed by one week of rest.
Courses are repeated every 3 weeks in the absence of disease progression or unacceptable
toxicity.

Patients are followed every 3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study over 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic non-small cell lung cancer for which no curative
therapy exists

- Stage IIIB with pleural effusion allowed

- Measurable or evaluable disease

- CNS metastases allowed if disease stable at least 4 weeks following completion of
surgery and/or radiotherapy and no anticonvulsant required

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

- SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN
if tumor involves liver)

Renal:

- Creatinine clearance at least 70 mL/min

Other:

- No other malignancies within past 3 years except nonmelanomatous skin cancer and
carcinoma in situ of the cervix

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective birth control

- No active infection

- No concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy for lung cancer

- No prior irinotecan or paclitaxel

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior wide field radiotherapy

- No prior radiotherapy to greater than 20% of bone marrow allowed

Surgery:

- See Disease Characteristics

- Recovered from prior surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

John R. Murren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Federal Government

Study ID:

CDR0000067608

NCT ID:

NCT00004924

Start Date:

March 1999

Completion Date:

February 2006

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

Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Northwestern Connecticut Oncology-Hematology Associates - TorringtonTorrington, Connecticut  06790