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

June 4, 2013 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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)

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

April 7, 2004

First Submitted That Met QC Criteria

April 7, 2004

First Posted (Estimate)

April 8, 2004

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-134
  • CDR0000358910 (Registry Identifier: PDQ (Physician Data Query))
  • ROCHE-N017352
  • KOS-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on epothilone D

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe