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

NCT00054314 | Completed Phase 2

• 3 other identifiers: DS 02-04RPCI-DS-0204BAYER-10653
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer

Interventions

ortataxel DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

IDN 5109

Condition Hierarchy (Ancestors)

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

Study Officials

• Nithya Ramnath, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: March 1, 2002
• Primary Completion: April 1, 2003
• Last Updated: September 26, 2022

Record last verified: 2022-09