Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 1, 1999

Last Updated Date

July 23, 2008

Start Date ^†

October 1999

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00003900 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer

Official Title ^†

A Phase II Study of Irinotecan (CPT-11) and Docetaxel (Taxotere) in Patients With Recurrent Non-Small Cell Lung Cancer

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and docetaxel in treating patients who have recurrent or metastatic non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Evaluate the response rate of previously treated patients with recurrent non-small cell lung cancer after treatment with irinotecan and docetaxel. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival in this patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 24 months.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment

Condition ^†

Lung Cancer

Intervention ^†

Drug: docetaxel
Drug: irinotecan hydrochloride

Study Arms / Comparison Groups

Publications *

Molina JR, Nikcevich D, Hillman S, Geyer S, Drevyanko T, Jett J, Verdirame J, Tazelaar H, Rowland K, Wos E, Kutteh L, Nair S, Fitch T, Flynn P, Stella P, Adjei AA. A Phase II NCCTG study of irinotecan and docetaxel in previously treated patients with non-small cell lung cancer. Cancer Invest. 2006 Jun-Jul;24(4):382-9.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Reconfirmation of NSCLC required only if complete response for greater than 1 year Measurable or evaluable disease Tumor shrinkage or stability for at least 4 weeks on initial chemotherapy CNS metastases allowed, if symptoms controlled for greater than 8 weeks after surgery or radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infection At least 5 years since any other prior malignancy except curatively treated basal or squamous cell skin cancer, carcinoma in situ, or other cancers No grade 2 or worse peripheral neuropathy No uncontrolled diabetes mellitus No other serious underlying disease Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No greater than 1 prior NSCLC chemotherapy regimen, excluding low dose cisplatin as a radiosensitizer No prior irinotecan or docetaxel At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other anticonvulsants

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00003900

Responsible Party

Secondary IDs ^††

NCCTG-982453

Study Sponsor ^†

North Central Cancer Treatment Group

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Alex A. Adjei, MD, PhD

Mayo Clinic

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.