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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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