Clinical trial NCT00499252: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-11
Enrollment: 51
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor Response
timeFrame: 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
measure: Frequency and Severity of Observed Adverse Effects
timeFrame: Every cycle during treatment and up to 5 years after completion of treatment
Secondary outcomes:
measure: Progression-free Survival
timeFrame: from study entry until disease progression, death or date of last contact.
measure: Overall Survival
timeFrame: from entry into the study to death or the date of last contact.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Colorado Gynecologic Oncology Group
state: Colorado
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: Lewes
country: United States
facility: Beebe Medical Center
state: Delaware
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Elkton
country: United States
facility: Union Hospital of Cecil County
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore-LIJ Health System CCOP
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Health Center West
state: Ohio
city: Tulsa
country: United States
facility: Cancer Care Associates-Midtown
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic Gynecological Oncology
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Gynecologic Oncology Group
name: Robert Coleman
role: PRINCIPAL_INVESTIGATOR
References: