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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00054314
First received: February 5, 2003
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Lung Cancer
Drug: ortataxel
Phase 2

Study Type: Interventional
Study Design: Masking: 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)

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: March 2002
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

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 at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic

  • 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

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

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

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054314

Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Nithya Ramnath, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054314     History of Changes
Other Study ID Numbers: DS 02-04, RPCI-DS-0204, BAYER-10653
Study First Received: February 5, 2003
Last Updated: January 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014