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An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)


- Determine the overall response rate, including partial and complete response, in
patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862.

- Determine the overall survival of patients treated with this drug.

- Determine duration of response and time to progression in patients treated with this

- Determine the quantitative and qualitative toxic effects of this drug in these

OUTLINE: This is a multicenter study.

Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity. Patients with responding disease
receive 2-4 additional courses beyond maximal response.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 14-84 patients will be accrued for this study.

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL


- 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


- Creatinine no greater than 1.5 times ULN


- No congestive heart failure

- No serious cardiac arrhythmias

- No active coronary disease or ischemia


- 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

- 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

- 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


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


- See Disease Characteristics

- More than 3 weeks since prior anticancer chemotherapy (6 weeks for mitomycin or

- 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


- More than 3 weeks since prior radiotherapy

- No concurrent non-palliative radiotherapy

- Palliative radiotherapy allowed provided that all of the following criteria are

- No progressive disease

- No more than 10% of the bone marrow is irradiated

- Radiation field does not encompass a target lesion


- More than 4 weeks since prior surgery

- No prior organ allograft


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Nithya Ramnath, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:

DS 02-04



Start Date:

March 2002

Completion Date:

Related Keywords:

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