GM-CSF and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00466960

Purpose

RATIONALE: Colony stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to cisplatin or carboplatin.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: sargramostim	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Cisplatin Paclitaxel Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum- Resistant Epithelial Ovarian Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical response [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between circulating monocytes and time to progression [ Designated as safety issue: No ]
Correlation between circulating dendritic cell count and maturation state with clinical response and response duration [ Designated as safety issue: No ]
Precursor frequency of circulating activated T lymphocytes against common ovarian cancer tumor associated antigens to measure the development of immunity to anti-tumor antigens [ Designated as safety issue: No ]
Precursor frequency of circulating T lymphocytes activated against foreign antigens (tt, influenza) [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine whether chronic sargramostim (GM-CSF) administration during and after cytotoxic chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer secondary remission than the immediately prior remission in patients with platinum-resistant advanced ovarian epithelial, fallopian tube, or primary peritoneal malignancies.

Secondary

Determine the extent to which chronic GM-CSF administration can increase the number of activated monocytes in these patients.
Determine the extent to which chronic GM-CSF administration can increase the number of activated peripheral circulating antigen presenting cells, such as dendritic cells and activated monocytes, in these patients.
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 these patients.
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 these patients.

OUTLINE: This is an open-label study.

Induction regimen: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15 and sargramostim (GM-CSF) subcutaneously (SC) on days 16-26. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Consolidation regimen: Patients receive GM-CSF SC on days 14-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo clinical and laboratory evaluations during study treatment.

After completion of study treatment, patients are followed once a month for 6 months and then every 3-6 months thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed advanced ovarian epithelial, fallopian tube, or primary peritoneal malignancies
- Recurrent disease
- No tumors of low malignant potential (borderline)
- Must have either primary or secondary platinum resistant or platinum refractory disease meeting 1 of the following criteria:
  - Persistent disease following chemotherapy using a platinum/taxane containing regimen
  - Recurrent disease diagnosed within 6 months of completing platinum based therapy
Must have an elevated serum CA 125 on two occasions > 27 days apart

PATIENT CHARACTERISTICS:

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 1.5 mg/dL (unless history of Gilbert's disease)
SGOT ≤ 2 times upper limit of normal
No history of allergy to sargramostim (GM-CSF) or paclitaxel albumin-stabilized nanoparticle formulation not manageable by pre-medication and/or slow drug infusion
No poorly controlled arrhythmias, unstable coronary artery disease, or myocardial infarction within the past 6 months
No concurrent neurotoxicity > grade 2

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior surgery
At least 3 weeks since prior chemotherapy or radiotherapy and recovered
No concurrent lithium carbonate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466960

Locations

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente 800-804-8824
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824
University of Washington School of Medicine	Recruiting
Seattle, Washington, United States, 98109-4714
Contact: Jennifer S. Childs, MPH, CCRP 206-616-2305 childj@u.washington.edu

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Ron Swensen, MD

Fred Hutchinson Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium ( Ron Swensen )
Study ID Numbers:	CDR0000542465, UWCC-6168, UWCC-UW-6168, UWCC-06-9975-H/B, UWCC-UW-128, ABRAXIS-FHCRC-6168
Study First Received:	April 25, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00466960
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

peritoneal cavity cancer
fallopian tube cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Study placed in the following topic categories:

Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Dental Caries
Genital Diseases, Female
Cisplatin
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female

Endocrine System Diseases
Carboplatin
Abdominal Neoplasms
Recurrence
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Digestive System Diseases
Paclitaxel
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Fallopian tube cancer
Endocrinopathy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009