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Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma

This is an open labeled, single arm phase II study of GM-CSF delivered daily without a break
in a population of healthy and fit women with evidence of recurrent but asymptomatic
mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal
cancer). The main goal is to determine the time to treatment termination due to disease
progression or toxicity.

Inclusion Criteria:

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

Exclusion Criteria:

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the time to treatment termination due to disease progression or toxicity

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

Richard T Penson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2004

Completion Date:

April 2010

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • Asymptomatic
  • Clinical trial
  • Phase II
  • GM-CSF
  • Immunotherapy
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms