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Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
soblidotin
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer Locally advanced or metastatic disease Demonstrates tumor progression Must have received 1 prior chemotherapy regimen Prior chemotherapy must have included a platinum agent Measurable disease At least 1 measurable lesion outside the field of any prior radiotherapy No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal Creatinine no greater than 1.5 times ULN Cardiac Ejection fraction at least 40% by MUGA Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychiatric disorder that would preclude giving informed consent or following study instruction No grade 2 or greater neurotoxicity No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years prior to study entry No other concurrent severe or uncontrolled underlying medical disease that would compromise patient safety and study outcome No concurrent serious infection PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic therapy Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics Recovered from prior radiotherapy No concurrent anticancer radiotherapy Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective Surgery At least 4 weeks since prior major surgery and recovered Other At least 4 weeks since prior myelosuppressive therapy More than 28 days since prior investigational drugs No other concurrent investigational drugs No other concurrent anticancer cytotoxic therapy

Sites / Locations

  • Medical Oncology and Hematology, P.C.
  • Barbara Ann Karmanos Cancer Institute
  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
May 15, 2012
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00061854
Brief Title
Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title
A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have progressive locally advanced or metastatic non-small cell lung cancer.
Detailed Description
OBJECTIVES: Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy. Determine the time to tumor progression in patients treated with this drug. Determine the median survival time and 12-month survival rate of patients treated with this drug. Determine the quantitative and qualitative toxic effects of this drug in these patients. Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1. Patients are followed for survival every 3 months after discontinuing study treatment. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
soblidotin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer Locally advanced or metastatic disease Demonstrates tumor progression Must have received 1 prior chemotherapy regimen Prior chemotherapy must have included a platinum agent Measurable disease At least 1 measurable lesion outside the field of any prior radiotherapy No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal Creatinine no greater than 1.5 times ULN Cardiac Ejection fraction at least 40% by MUGA Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychiatric disorder that would preclude giving informed consent or following study instruction No grade 2 or greater neurotoxicity No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years prior to study entry No other concurrent severe or uncontrolled underlying medical disease that would compromise patient safety and study outcome No concurrent serious infection PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic therapy Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics Recovered from prior radiotherapy No concurrent anticancer radiotherapy Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective Surgery At least 4 weeks since prior major surgery and recovered Other At least 4 weeks since prior myelosuppressive therapy More than 28 days since prior investigational drugs No other concurrent investigational drugs No other concurrent anticancer cytotoxic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Cheverton, MD, ChB, MMED, RadT
Organizational Affiliation
Daiichi Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Oncology and Hematology, P.C.
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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