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DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
exatecan mesylate
Sponsored by
Daiichi Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable, metastatic, or recurrent non-small cell lung cancer Stage IIIB or IV Measurable disease No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No other malignancy within past 5 years except nonmelanomatous skin cancer No overt psychosis, mental disability, or incompetence No life threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater than 25% of the bone marrow No concurrent radiotherapy Surgery: No concurrent surgery Other: At least 28 days since prior investigational drugs No other concurrent investigational drugs during or within 28 days after final dose of study drug No concurrent drugs that induce or inhibit CYP3A enzyme

Sites / Locations

  • Helsinki University Central Hospital
  • Thoraxklinik Rohrbach
  • Ospedale Bellaria
  • Academisch Ziekenhuis der Vrije Universiteit
  • Christie Hospital N.H.S. Trust
  • Oxford Radcliffe Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
July 9, 2013
Sponsor
Daiichi Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00005091
Brief Title
DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Official Title
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer as First Line Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Pharmaceuticals

4. Oversight

5. Study Description

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 DX-8951f in treating patients who have previously untreated stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in previously untreated patients with stage IIIB or IV non-small cell lung cancer. II. Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Assess the time to progression and survival status of these patients. OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
exatecan mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable, metastatic, or recurrent non-small cell lung cancer Stage IIIB or IV Measurable disease No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No other malignancy within past 5 years except nonmelanomatous skin cancer No overt psychosis, mental disability, or incompetence No life threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater than 25% of the bone marrow No concurrent radiotherapy Surgery: No concurrent surgery Other: At least 28 days since prior investigational drugs No other concurrent investigational drugs during or within 28 days after final dose of study drug No concurrent drugs that induce or inhibit CYP3A enzyme
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Thatcher, PhD, FRCP
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FIN-0-0029
Country
Finland
Facility Name
Thoraxklinik Rohrbach
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Facility Name
Ospedale Bellaria
City
Bologna
ZIP/Postal Code
I-40139
Country
Italy
Facility Name
Academisch Ziekenhuis der Vrije Universiteit
City
Amsterdam
ZIP/Postal Code
1117 MB
Country
Netherlands
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
12871785
Citation
Braybrooke JP, Ranson M, Manegold C, Mattson K, Thatcher N, Cheverton P, Sekiguchi M, Suzuki M, Oyama R, Talbot DC. Phase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer. Lung Cancer. 2003 Aug;41(2):215-9. doi: 10.1016/s0169-5002(03)00190-9.
Results Reference
result

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DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

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