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
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, see Learn About Clinical Studies.

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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014