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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054314
• Other study ID #: DS 02-04
• Secondary ID: RPCI-DS-0204BAYE
• Status: Completed
• Phase: Phase 2
• Start date: March 2002

Study information

• Verified date: September 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• ortataxel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute