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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Naiyer Rizvi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

03-134

NCT ID:

NCT00081107

Start Date:

December 2003

Completion Date:

December 2004

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021