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A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum-Refractory/Resistant Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

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Trial Information

A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum-Refractory/Resistant Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancer


PRIMARY OBJECTIVES:

I. To determine whether chronic GM-CSF administration during and after cytotoxic
chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer
remission than experienced in the most recent platinum-containing regimen.

SECONDARY OBJECTIVES:

I. To determine the extent to which chronic GM-CSF administration can increase the number of
activated monocytes in patients with advanced stage epithelial ovarian cancer.

II. To determine the extent to which chronic GM-CSF administration can increase the number
and activation state of peripheral circulating antigen presenting cells, such as dendritic
cells and activated monocytes, in patients with advanced epithelial ovarian cancer.

III. To determine the extent to which chronic GM-CSF administration can increase the number
and functional status of T cells that recognize tumor specific antigens in patients with
advanced stage epithelial ovarian cancer.

IV. To determine the extent to which chronic GM-CSF administration can increase the number
and functional status of antigen specific T cells that recognize foreign pathogens in
patients with advanced stage epithelial ovarian cancer.

OUTLINE:

INDUCTION THERAPY: Patients receive GM-CSF subcutaneously (SC) once daily on days 16-26.
Patients also receive paclitaxel albumin-stabilized nanoparticle formulation intravenously
(IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses
in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF
SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 6 months and then
every 3 months thereafter.


Inclusion Criteria:



- Patients must have histologically proven epithelial ovarian, fallopian tube or
primary peritoneal malignancies, excluding tumors of low malignant potential
(borderline)

- Patients with the following histologic epithelial cell types are eligible: serous
adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma,
transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not
otherwise specified

- Patients must have either primary platinum refractory or resistant carcinoma or
secondary platinum resistant disease:

1. Primary platinum refractory disease is defined as progression of disease on
initial platinum-based chemotherapy or persistent disease at the conclusion of
the initial platinum-based chemotherapy course associated with the primary
debulking surgery.

2. Primary platinum resistant disease is defined as recurrence of carcinoma within
6 months (+ 14 days) of completion of initial platinum-based chemotherapy
associated with the primary debulking surgery. (The 14 day window is to allow
study entry for those patients where evidence clearly suggests that had an
assessment been made early the patient would have met the 6 month time line.
This will be determined by the study principal investigator [P.I.])

3. Secondary platinum resistant disease is defined as meeting any one of the listed
criteria during or following a subsequent platinum containing regimen.

- Patients must have an elevated serum cancer antigen (CA)125 on two occasions greater
than 7 days apart

- Absolute neutrophil count >= 1500/uL

- Platelets >= 100,000/uL

- Creatinine =< 2.0 mg/dL

- Total bilirubin =< 1.5 mg/dL (unless history of Gilbert's disease)

- Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x upper limit of normal (ULN)
or < 5 x ULN with documented report of hepatic metastases

- Patients must have recovered from effects of recent surgery, radiotherapy, or
chemotherapy; at least three weeks must have elapsed since prior chemotherapy or
radiation therapy

Exclusion Criteria:

- Patient has an allergic history to paclitaxel or GM-CSF, not manageable by
pre-medication and/or slow drug infusion

- Patient has poorly controlled arrhythmias or unstable coronary artery disease or has
had a myocardial infarction within the last six months

- Patient with active pulmonary edema or pleural effusion

- Active infection requiring IV antibiotics

- Patient currently requires lithium, (due to drug interaction with GM-CSF [Leukine])

- Patient currently presents with a neurotoxicity > Grade 1

- Women of childbearing potential

- Patients with a history of other invasive malignancies, within the previous 5 years
are excluded, with the exception of non-melanoma skin cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Barbara Goff

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6168

NCT ID:

NCT00466960

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Brenner Tumor
  • Fallopian Tube Cancer
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Brenner Tumor
  • Carcinoma
  • Cystadenocarcinoma
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Carcinoma, Endometrioid
  • Cystadenocarcinoma, Mucinous
  • Cystadenocarcinoma, Serous
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109