Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma
Patients must have a history of histologic or cytologic diagnosis of primary ovarian,
primary peritoneal or tubal carcinoma.
Patients must be asymptomatic from their cancer.
Patients must have evidence of recurrent carcinoma, as determined by:
- A rising CA-125 serum level greater than 35 U/mL or two successive rising values with
the most recent value at least 3 times the nadir value.
- Or evidence of evaluable or measurable disease by x-ray or CT scan. Patients may not
receive concurrent antineoplastic therapy. All hormonal therapy used as a treatment
modality (i.e. tamoxifen, arimidex, etc) must be stopped prior to treatment on
Age > 18 years. ECOG performance status< 2
Known severe hypersensitivity to GM-CSF Other coexisting malignancies or malignancies
diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical
cancer in situ or concurrent superficial or stage IB endometrial carcinoma Concomitant use
of anti-neoplastic therapy Treatment with a non-FDA approved or investigational drug
within 30 days before Day 1 of trial treatment Any unresolved chronic toxicity greater
then CTC grade 2 from previous anticancer therapy (except alopecia) Serum creatinine level
greater than CTC grade 2 (£ 1.5 x ULN) Pregnancy or breast feeding (women of childbearing
potential) Severe or uncontrolled systemic disease (e.g., unstable or uncompensated
respiratory, cardiac, hepatic, or renal disease) as judged by the investigator.
Significant clinical disorder or laboratory finding that makes it potentially unsafe for
the subject to participate in the trial as judged by the investigator.
Patients currently receiving other investigational antineoplastic agents, on systemic
chemotherapy or under radiation therapy treatment.
Patients with clinical and/or radiographic evidence of current or impending bowel
Performance status < 1 Ability to understand and the willingness to sign a written
informed consent document.