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

NCT ID: NCT00054314

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31

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.

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ortataxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Nithya Ramnath, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Other Identifiers

RPCI-DS-0204

Identifier Type: -

Identifier Source: secondary_id

BAYER-10653

Identifier Type: -

Identifier Source: secondary_id

DS 02-04

Identifier Type: -

Identifier Source: org_study_id