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	Biological: sargramostim Drug: paclitaxel albumin-stabilized nanoparticle formulation	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

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

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
Tumor Vaccine Group at the University of Washington	Recruiting
Seattle, Washington, United States, 98109
Contact: Nicole Bates 206-543-6620

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Ron Swensen, MD

University of Washington

More Information

Additional Information:

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

No publications provided

Responsible Party:	University of Washington School of Medicine ( 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:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00466960 History of Changes
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:

Fallopian Tube Cancer
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Cisplatin
Peritoneal Diseases
Ovarian Cancer
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents

Carboplatin
Abdominal Neoplasms
Ovarian Epithelial Cancer
Recurrence
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female

Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009