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

A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Ovarian Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma
• Intervention / Treatment: Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80010
      • Colorado Gynecologic Oncology Group
  • Connecticut
    • New Britain, Connecticut, United States, 06050
      • The Hospital of Central Connecticut
  • Delaware
    • Lewes, Delaware, United States, 19958
      • Beebe Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Maryland
    • Elkton, Maryland, United States, 21921
      • Union Hospital of Cecil County
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • Manhasset, New York, United States, 11030
      • North Shore-LIJ Health System CCOP
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43222
      • Mount Carmel Health Center West
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Cancer Care Associates-Midtown
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Allentown, Pennsylvania, United States, 18105
      • LeHigh Valley Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital
  • Texas
    • Galveston, Texas, United States, 77555-0565
      • University of Texas Medical Branch at Galveston
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Carilion Clinic Gynecological Oncology
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Other Names: ABI-007; Abraxane; ABI 007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response	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.	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
Frequency and Severity of Observed Adverse Effects		Every cycle during treatment and up to 5 years after completion of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	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.	from study entry until disease progression, death or date of last contact.
Overall Survival		from entry into the study to death or the date of last contact.

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Robert Coleman, Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 10, 2007
• First Submitted That Met QC Criteria: July 10, 2007
• First Posted (Estimate): July 11, 2007

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Carcinoma; Recurrence; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: GOG-0126R (Other Identifier: CTEP); U10CA027469 (U.S. NIH Grant/Contract); NCI-2009-00575 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); ABRAXIS-ABX-005; CDR0000553208