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

September 23, 2022 updated by: Roswell Park Cancer Institute

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Roswell Park Cancer Institute

Investigators

  • Study Chair: Nithya Ramnath, MD, Roswell Park Cancer Institute

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

March 1, 2002

Primary Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimate)

February 6, 2003

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS 02-04
  • RPCI-DS-0204
  • BAYER-10653

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.

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