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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: irinotecan hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 6X3
      • Saskatchewan Cancer Agency
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259-5404
      • CCOP - Scottsdale Oncology Program
  • Illinois
    • Peoria, Illinois, United States, 61602
      • CCOP - Illinois Oncology Research Association
    • Urbana, Illinois, United States, 61801
      • CCOP - Carle Cancer Center
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403-1206
      • CCOP - Cedar Rapids Oncology Project
    • Des Moines, Iowa, United States, 50309-1016
      • CCOP - Iowa Oncology Research Association
    • Sioux City, Iowa, United States, 51101-1733
      • Siouxland Hematology-Oncology
  • Kansas
    • Wichita, Kansas, United States, 67214-3882
      • CCOP - Wichita
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • CCOP - Duluth
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Clinic
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • CCOP - Missouri Valley Cancer Consortium
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Quain & Ramstad Clinic, P.C.
    • Fargo, North Dakota, United States, 58122
      • CCOP - Merit Care Hospital
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health Systems
  • Ohio
    • Toledo, Ohio, United States, 43623-3456
      • CCOP - Toledo Community Hospital Oncology Program
  • South Dakota
    • Rapid City, South Dakota, United States, 57709
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57105-1080
      • CCOP - Sioux Community Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: irinotecan + docetaxel; 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.	Drug: docetaxel; Drug: irinotecan hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response rate	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	Up to 5 years

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General 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. doi: 10.1080/07357900600705318.

Study record dates

Study Major Dates

• Study Start: October 1, 1999
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: April 30, 2004
• First Posted (Estimate): May 3, 2004

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: July 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IV non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Docetaxel; Irinotecan
• Other Study ID Numbers: NCCTG-982453; CDR0000067071 (Registry Identifier: PDQ (Physician Data Query))