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


Phase 2
N/A
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- 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.

- Determine the toxicity of this drug in these patients.

Secondary

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- 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

- No concurrent amifostine or other protective reagents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Safety Issue:

No

Principal Investigator

Robert L. Coleman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000553208

NCT ID:

NCT00499252

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Tufts-NEMC Cancer CenterBoston, Massachusetts  02111
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
University of Texas Medical BranchGalveston, Texas  77555-1329
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Alamance Cancer Center at Alamance Regional Medical CenterBurlington, North Carolina  27216
Colorado Gynecologic Oncology Group, PCAurora, Colorado  80010
Central Georgia Gynecologic OncologyMacon, Georgia  31201
Women's Cancer Care AssociatesAlbany, New York  12208