Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

NCT00081107 | Completed Phase 2

• 4 other identifiers: 03-134CDR0000358910ROCHE-N017352KOS-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

epothilone D DRUG

Eligibility Criteria

• Age: 18 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 (NSCLC) * Stage IIIB\* or IV disease NOTE: \*Due to malignant pleural effusion or supraclavicular lymph node involvement only * Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease * Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity * At least 1 site of unidimensionally measurable disease by physical exam or radiography * No known CNS metastases or leptomeningeal metastases requiring corticosteroids PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8 g/dL * Platelet count ≥ 75,000/mm\^3 Hepatic * AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases) * Alkaline phosphatase ≤ 5 times ULN * Bilirubin ≤ 1.8 mg/dL Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No New York Heart Association class III or IV congestive heart failure * No personal or family history of congenital long QT syndrome * No QTc interval \> 450 msec (males) or \> 470 msec (females) by ECG Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No preexisting neuropathy ≥ grade 2 * No other malignancy within the past 5 years except for the following: * Cured basal cell skin cancer * Carcinoma in situ of the cervix or urinary bladder * Stage T1 or T2 prostate cancer with prostate-specific antigen \< 2 ng/mL * No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy * No infection requiring parenteral or oral anti-infective therapy * No weight loss of ≥ 10% within the past 3 months * No altered mental status or psychiatric illness that would preclude giving informed consent * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim \[GM-CSF\]) * No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim \[G-CSF\]) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics * At least 3 weeks since prior surgery and recovered Other * Prior adjuvant or neoadjuvant therapy allowed * Prior radiosensitizers allowed * At least 2 weeks since prior gefitinib * More than 3 weeks since prior investigational agents (therapeutic or diagnostic) * No other concurrent investigational agents * No other concurrent anticancer treatment

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

desoxyepothilone B

Condition Hierarchy (Ancestors)

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

Study Officials

• Naiyer Rizvi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: December 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)