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BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer

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. Identifier: NCT00054314
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : January 31, 2013
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

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 BAY 59-8862 in treating patients who have non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: ortataxel Phase 2

Detailed Description:


  • Determine the overall response rate, including partial and complete response, in patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862.
  • Determine the overall survival of patients treated with this drug.
  • Determine duration of response and time to progression in patients treated with this drug.
  • Determine the quantitative and qualitative toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2-4 additional courses beyond maximal response.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 14-84 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)
Study Start Date : March 2002
Actual Primary Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer
  • Measurable disease

    • A CNS lesion cannot be the sole target lesion
  • Must be taxane-resistant as defined by the following criteria:

    • At least 1 prior course (3 weeks of continuous therapy) of a taxane
    • Progressive disease developed either during or within 6 months after therapy
  • No metastatic brain or meningeal tumors unless the following criteria apply:

    • More than 6 months since definitive therapy
    • Negative imaging study within the past 4 weeks
    • Clinically stable with respect to the tumor
    • No concurrent acute steroid therapy or taper

      • Chronic steroids allowed provided dose is stable for 1 month before and after screening radiography



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 2.5 times ULN (5 times ULN if liver involvement)
  • No chronic hepatitis B or C


  • Creatinine no greater than 1.5 times ULN


  • No congestive heart failure
  • No serious cardiac arrhythmias
  • No active coronary disease or ischemia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • HIV negative
  • No active clinically serious infection
  • No history of seizure disorder

    • History of seizures related to brain metastasis allowed if seizure free for the past 2 months
  • No prior hypersensitivity to taxane compounds that was unmanageable with premedication
  • No pre-existing peripheral neuropathy greater than grade 1
  • No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, and T1)
  • No substance abuse
  • No medical, psychological, or social condition that would preclude study participation or evaluation
  • No condition that is unstable or would jeopardize patient safety and study compliance


Biologic therapy

  • More than 3 weeks since prior anticancer immunotherapy
  • More than 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF])
  • More than 4 months since prior bone marrow transplantation or stem cell rescue
  • No concurrent anticancer immunotherapy
  • Concurrent epoetin alfa allowed if dose is stable for the past 2 months


  • See Disease Characteristics
  • More than 3 weeks since prior anticancer chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • No more than 2 prior anticancer chemotherapy regimens (adjuvant therapy is not included unless cancer recurred during or within 6 months after completion of adjuvant therapy)
  • No prior oxaliplatin
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics


  • More than 3 weeks since prior radiotherapy
  • No concurrent non-palliative radiotherapy

    • Palliative radiotherapy allowed provided that all of the following criteria are met:

      • No progressive disease
      • No more than 10% of the bone marrow is irradiated
      • Radiation field does not encompass a target lesion


  • More than 4 weeks since prior surgery
  • No prior organ allograft


  • More than 4 weeks since prior investigational drug therapy
  • No concurrent non-conventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements that would interfere with study endpoints
  • No other concurrent investigational drug therapy
  • No other concurrent anticancer therapy

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 identifier (NCT number): NCT00054314

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Nithya Ramnath, MD Roswell Park Cancer Institute

Layout table for additonal information Identifier: NCT00054314     History of Changes
Other Study ID Numbers: DS 02-04
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013
Keywords provided by Roswell Park Cancer Institute:
recurrent non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
IDN 5109
Antineoplastic Agents