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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00081107
First Posted: April 8, 2004
Last Update Posted: June 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center
  Purpose

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.


Condition Intervention Phase
Lung Cancer Drug: epothilone D Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: December 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081107


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Naiyer Rizvi, MD Memorial Sloan Kettering Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00081107     History of Changes
Other Study ID Numbers: 03-134
CDR0000358910 ( Registry Identifier: PDQ (Physician Data Query) )
ROCHE-N017352
KOS-201
First Submitted: April 7, 2004
First Posted: April 8, 2004
Last Update Posted: June 5, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents