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

NCT ID: NCT00081107

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2004-12-31

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.

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy.

Secondary

• Determine the safety of this drug in these patients.
• Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug.
• Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment.
• Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients.

OUTLINE: This is a multicenter, open-label study.

Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

epothilone D

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Naiyer Rizvi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000358910

Identifier Type: REGISTRY

Identifier Source: secondary_id

ROCHE-N017352

Identifier Type: -

Identifier Source: secondary_id

KOS-201

Identifier Type: -

Identifier Source: secondary_id

03-134

Identifier Type: -

Identifier Source: org_study_id