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Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epothilone D
Sponsored by
Memorial Sloan Kettering Cancer Center
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 non-small cell lung cancer (NSCLC) Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or supraclavicular lymph node involvement only Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity At least 1 site of unidimensionally measurable disease by physical exam or radiography No known CNS metastases or leptomeningeal metastases requiring corticosteroids PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8 g/dL Platelet count ≥ 75,000/mm^3 Hepatic AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases) Alkaline phosphatase ≤ 5 times ULN Bilirubin ≤ 1.8 mg/dL Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No New York Heart Association class III or IV congestive heart failure No personal or family history of congenital long QT syndrome No QTc interval > 450 msec (males) or > 470 msec (females) by ECG Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No preexisting neuropathy ≥ grade 2 No other malignancy within the past 5 years except for the following: Cured basal cell skin cancer Carcinoma in situ of the cervix or urinary bladder Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy No infection requiring parenteral or oral anti-infective therapy No weight loss of ≥ 10% within the past 3 months No altered mental status or psychiatric illness that would preclude giving informed consent No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF]) No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim [G-CSF]) Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics At least 3 weeks since prior surgery and recovered Other Prior adjuvant or neoadjuvant therapy allowed Prior radiosensitizers allowed At least 2 weeks since prior gefitinib More than 3 weeks since prior investigational agents (therapeutic or diagnostic) No other concurrent investigational agents No other concurrent anticancer treatment

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2004
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00081107
Brief Title
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Official Title
A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.
Detailed Description
OBJECTIVES: Primary Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy. Secondary Determine the safety of this drug in these patients. Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug. Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment. Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. OUTLINE: This is a multicenter, open-label study. Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 33-85 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
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
epothilone D

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or supraclavicular lymph node involvement only Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity At least 1 site of unidimensionally measurable disease by physical exam or radiography No known CNS metastases or leptomeningeal metastases requiring corticosteroids PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8 g/dL Platelet count ≥ 75,000/mm^3 Hepatic AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases) Alkaline phosphatase ≤ 5 times ULN Bilirubin ≤ 1.8 mg/dL Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No New York Heart Association class III or IV congestive heart failure No personal or family history of congenital long QT syndrome No QTc interval > 450 msec (males) or > 470 msec (females) by ECG Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No preexisting neuropathy ≥ grade 2 No other malignancy within the past 5 years except for the following: Cured basal cell skin cancer Carcinoma in situ of the cervix or urinary bladder Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy No infection requiring parenteral or oral anti-infective therapy No weight loss of ≥ 10% within the past 3 months No altered mental status or psychiatric illness that would preclude giving informed consent No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF]) No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim [G-CSF]) Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics At least 3 weeks since prior surgery and recovered Other Prior adjuvant or neoadjuvant therapy allowed Prior radiosensitizers allowed At least 2 weeks since prior gefitinib More than 3 weeks since prior investigational agents (therapeutic or diagnostic) No other concurrent investigational agents No other concurrent anticancer treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naiyer Rizvi, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
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

Learn more about this trial

Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

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