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

NCT ID: NCT00499252

Last Updated: 2018-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30

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.

Conditions

Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Intervention Type: DRUG

Interventions

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Intervention Type: DRUG

Other Intervention Names

ABI 007; ABI-007; Abraxane

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Coleman

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Colorado Gynecologic Oncology Group

Aurora, Colorado, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Rush University Medical Center

Chicago, Illinois, United States

Union Hospital of Cecil County

Elkton, Maryland, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

North Shore University Hospital

Manhasset, New York, United States

North Shore-LIJ Health System CCOP

Manhasset, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Mount Carmel Health Center West

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

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2009-00575

Identifier Type: REGISTRY

Identifier Source: secondary_id

ABRAXIS-ABX-005

Identifier Type: -

Identifier Source: secondary_id

CDR0000553208

Identifier Type: -

Identifier Source: secondary_id

GOG-0126R

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0126R

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0126R

Identifier Type: -

Identifier Source: org_study_id