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Phase 2
18 Years
Not Enrolling
Carcinoma, Non-small-cell Lung

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Trial Information

Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer

- Bidimensionally measurable disease

- Progressed following therapy with one prior cisplatin or carboplatin based
chemotherapy regimen for Stage III or IV or metastatic recurrent disease

- Adequate hematologic function as defined by: absolute neutrophils =/> 2,000/mm3, and
platelets > 125,000/mm3

- Adequate hepatic function as defined by: serum bilirubin=/<1.5 times the upper
institutional limits of normal, ALT =/< 2.5 times the upper institutional limits of
normal (=/<5 times the upper institutional limits of normal if hepatic metastases are

- Adequate renal function as defined: by serum creatine =/< 1.5 times the upper limits
of normal

- Adequate recovery from recent surgery, chemotherapy and radiation therapy. At least
one week must have elapsed from the time of a minor surgery, at least 3 weeks for
major surgery, chemotherapy and radiation therapy

- Life expectancy of at least 12 weeks

- ECOG performance status of 0-1

- At least 18 years old

- Willing and able to give written informed consent

- Accessible for treatment and follow-up. Patients enrolled in this trial must be
treated at the participating center

- Women of Child Bearing Potential (WOCP) must have a negative serum or urine pregnancy
test (minimum sensitivity IU/L or equivalent units of HCG) within 72 hours prior to
start of study medication.

WOCBP include any female who has experienced menarche and who has not undergone successful
surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy)
or is not postmenopausal [defined as amenorrhea=/>12 consecutive months; or women on
hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH)
level > 35mIU/mL]. Even women who are using oral, implanted or, injectable intrauterine
device or barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy or
practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered
to be of child bearing potential.

Exclusion Criteria

- More than one prior chemotherapy regimen for Stage IIIB or IV or for metastatic
recurrent disease. Prior adjuvant or neoadjuvant chemotherapy is allowed.

- Patients who are candidates for curative resection.

- CTC Grade 2 or greater neuropathy (motor or sensory)

- Known brain metastases

- Prior radiation must have not included major bone marrow containing areas (pelvis,
lumbar, spine) and must not have contained a target lesion as the only measurable
lesion. A recovery period of at least 3 weeks after completion of radiotherapy is
required prior to enrollment.

- Myocardial infarction, unstable angina, or any history of congestive heart failure
within six months of study therapy

- Pregnant or breast-feeding women, or sexually active women of childbearing potential
not using an adequate method of birth control.

- Sexually active fertile men, whose partners are women of childbearing potential,
unless using an adequate method of birth control

- Serious intercurrent infections, or nonmalignant medical illnesses that are
controlled or whose control may be jeopardized by the complications of this therapy

- Psychiatric disorders or other conditions rendering the patient incapable of
complying with the requirements of the the protocol

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

February 2001

Completion Date:

April 2004

Related Keywords:

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



Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Ochsner Cancer Institute New Orleans, Louisiana  70121
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Un of California Davis Cancer Center Sacramento, California  958177
Mount Sinai Medical Center Miami Beach, Florida  33140
H Lee Moffitt Cancer Center Tampa, Florida  33612
Rush Presbyterian St Lukes ME Chicago, Illinois  60612-3828
Consultants in Blood Disorders Louisville, Kentucky  40207
University of Maryland Greenbaum Cancer Center Baltimore, Maryland  21201
Lahey Clinic Burlington, Massachusetts  01805
University of Missouri/Ellis Fischel Cancer Center Columbia, Missouri  65203
Dartmouth-Hitchcock /Norris Cotton Cancer Center Lebanon, New Hampshire  03756
Unviversity of North Carolina Chapel Hill, North Carolina  27599
Vanderbilt University Med School Div of Medical Oncology Nashville, Tennessee  37232-5536
Sarah Cannon Cancer Center Nashville, Tennessee  37203
University of Wisconsin Hospital Madison, Wisconsin  53792