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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 has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00499252
First received: July 10, 2007
Last updated: December 29, 2014
Last verified: December 2014
  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. 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.


Condition Intervention Phase
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Tumor Response [ Time Frame: every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels ] [ Designated as safety issue: No ]

    Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

    CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.


  • Frequency and Severity of Observed Adverse Effects [ Time Frame: Every cycle during treatment ] [ Designated as safety issue: Yes ]
    Refer to Adverse Events (AE) tables.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: from study entry until disease progression, death or date of last contact. ] [ Designated as safety issue: No ]

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.

    CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.


  • Overall Survival [ Time Frame: from entry into the study to death or the date of last contact. ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: June 2007
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (paclitaxel albumin-stabilized nanoparticle)
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.
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Other Names:
  • ABI 007
  • ABI-007
  • Abraxane

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

II. Determine the toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. 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

Inclusion Criteria:

  • 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
  • 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
  • No concurrent amifostine or other protective reagents
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499252

Locations
United States, Colorado
Colorado Gynecologic Oncology Group
Aurora, Colorado, United States, 80010
United States, Connecticut
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
North Shore-LIJ Health System CCOP
Manhasset, New York, United States, 11030
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
United States, Oklahoma
Cancer Care Associates-Midtown
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0565
United States, Virginia
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States, 24016
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Robert Coleman Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00499252     History of Changes
Other Study ID Numbers: GOG-0126R, NCI-2009-00575, ABRAXIS-ABX-005, CDR0000553208, GOG-0126R, GOG-0126R, U10CA027469
Study First Received: July 10, 2007
Results First Received: October 23, 2013
Last Updated: December 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Fallopian Tube Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Urogenital Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on February 26, 2015