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

Lung Cancer Clinical Trial

Official title:

A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081107
• Other study ID #: 03-134
• Secondary ID: CDR0000358910ROC
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: June 4, 2013
• Start date: December 2003
• Est. completion date: December 2004

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• epothilone D

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,