Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Phase 2

Completed

Conditions: Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma

Interventions: Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Registration Number: NCT00499252

Lead Sponsor: Gynecologic Oncology Group

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 51

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (paclitaxel albumin-stabilized nanoparticle)	Paclitaxel Albumin-Stabilized Nanoparticle Formulation	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.

Primary Outcome Measures

Name	Time	Method
Tumor Response	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	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	Every cycle during treatment and up to 5 years after completion of treatment

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	from study entry until disease progression, death or date of last contact.	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	from entry into the study to death or the date of last contact.

Trial Locations

Locations (20): University of Texas Medical Branch at Galveston
🇺🇸
Galveston, Texas, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Beebe Medical Center
🇺🇸
Lewes, Delaware, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
North Shore-LIJ Health System CCOP
🇺🇸
Manhasset, New York, United States
Mount Carmel Health Center West
🇺🇸
Columbus, Ohio, United States
Carilion Clinic Gynecological Oncology
🇺🇸
Roanoke, Virginia, United States
The Hospital of Central Connecticut
🇺🇸
New Britain, Connecticut, United States
Union Hospital of Cecil County
🇺🇸
Elkton, Maryland, United States
University of Massachusetts Medical School
🇺🇸
Worcester, Massachusetts, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
North Shore University Hospital
🇺🇸
Manhasset, New York, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
Cancer Care Associates-Midtown
🇺🇸
Tulsa, Oklahoma, United States
Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸
Allentown, Pennsylvania, United States
Women and Infants Hospital
🇺🇸
Providence, Rhode Island, United States
Colorado Gynecologic Oncology Group
🇺🇸
Aurora, Colorado, United States