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Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00499252
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


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

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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

Primary Outcome Measures:
  • Frequency and duration of objective response [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: June 2007
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), in terms of frequency and duration of objective response, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.
  • Determine the toxicity of this drug in these patients.

Secondary

  • Determine the duration of progression-free survival and overall survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Ovarian epithelial cancer
    • Fallopian tube cancer
    • Primary peritoneal carcinoma
  • Recurrent or persistent disease
  • Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease

    • Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, or extended therapy administered after a surgical or nonsurgical assessment
    • Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel
  • Platinum-resistant or refractory disease, defined by 1 of the following:

    • Treatment-free interval of < 6 months after completion of platinum-based therapy
    • Persistent disease at completion of primary platinum-based therapy
    • Progressive disease during platinum-based therapy
  • Paclitaxel-resistant disease, defined as having had a treatment-free interval < 6 months or shown disease progression during paclitaxel-based therapy

    • Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have ≥ 1 target lesion that can be used to assess response

    • Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or biopsy confirms persistence ≥ 90 days after completion of radiotherapy
  • Not a candidate for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No active infection requiring antibiotics
  • No sensory or motor neuropathy > grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • PT INR ≤ 1.5 or in-range INR 2-3 (if patient is on a stable dose of therapeutic warfarin)
  • PTT < 1.2 times control
  • No concurrent serious medical or psychiatric illness, including serious active infection
  • No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
  • No uncompensated congestive heart failure or symptomatic coronary artery disease
  • No myocardial infarction within the past 6 months
  • No active bleeding
  • No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
  • No history of allergic reactions attributed to chemical or biological composition to paclitaxel or other study agents

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery, radiotherapy, or chemotherapy
  • No prior paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®)
  • No prior cancer treatment that would preclude study therapy
  • No additional prior cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens
  • One additional prior noncytotoxic regimen (i.e., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for management of recurrent or persistent disease allowed
  • At least 1 week since prior hormonal therapy directed at the malignant tumor

    • Concurrent hormone replacement therapy allowed
  • At least 3 weeks since other prior therapy directed at the malignant tumor, including biologic therapy, immunologic agents, or radiotherapy
  • More than 5 years since prior chemotherapy for any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer

    • Prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed > 3 years ago and patient remains free of recurrent or metastatic disease
  • More than 5 years since prior radiotherapy to any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer

    • Prior radiotherapy for localized breast cancer, cancer of the head and neck, or skin cancer allowed provided it was completed > 3 years ago and patient remains free of recurrent or metastatic disease
  • No prior radiotherapy to > 25% of marrow-bearing areas
  • No concurrent amifostine or other protective reagents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499252

  Show 49 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Robert L. Coleman, MD M.D. Anderson Cancer Center
Investigator: Thomas J. Herzog, MD Herbert Irving Comprehensive Cancer Center
  More Information

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

Study ID Numbers: CDR0000553208, GOG-0126R, ABRAXIS-ABX-005
Study First Received: July 10, 2007
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00499252  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer

Study placed in the following topic categories:
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Paclitaxel
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Endocrine Gland Neoplasms

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 16, 2009