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

Completed · Phase 2

Conditions studied: Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma

In brief

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.

Key facts

Study ID

NCT00499252

Run by

Gynecologic Oncology Group

People needed

51

Starts

2007-06-01

Last updated by the study team

2018-01-11

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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