Brief Title
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Official Title
A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumor Response
Secondary Outcome
Progression-free Survival
Condition
Fallopian Tube Carcinoma
Intervention
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Study Arms / Comparison Groups
Treatment (paclitaxel albumin-stabilized nanoparticle)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
51
Start Date
June 2007
Primary Completion Date
July 2011
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Robert Coleman, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00499252
Organization ID
GOG-0126R
Secondary IDs
NCI-2009-00575
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Robert Coleman, Principal Investigator, Gynecologic Oncology Group
Verification Date
March 2015