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A Phase II Evaluation of Elesclomol and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Sponsor: GOG, IND# 110072)


Phase 2
18 Years
N/A
Not Enrolling
Both
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of Elesclomol and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Sponsor: GOG, IND# 110072)


OBJECTIVES:

Primary

- To estimate the antitumor activity of elesclomol sodium and paclitaxel, in terms of the
frequency of objective tumor responses, in patients with persistent or recurrent
platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.

- To determine the nature and degree of toxicity of elesclomol sodium and paclitaxel in
these patients.

Secondary

- To estimate the progression-free survival and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive elesclomol sodium IV over 1 hour and paclitaxel IV over 1 hour on days 1,
8, and 15. Courses repeat 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 ovarian epithelial, fallopian tube, or primary peritoneal
carcinoma, including any of the following epithelial cell types:

- Serous adenocarcinoma

- Endometrioid adenocarcinoma

- Mucinous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner tumor

- Adenocarcinoma not otherwise specified

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 10 mm by CT
scan, MRI, or caliper measurement by clinical exam or ≥ 20 mm by chest x-ray

- Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

- Must have ≥ 1 target lesion to assess response as defined by RECIST 1.1 criteria

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless there is documented disease progression or a biopsy is obtained
to confirm persistence ≥ 90 days after completion of radiotherapy

- Must have received 1 prior platinum-based chemotherapeutic regimen containing
carboplatin, cisplatin, or another organoplatinum compound for management of the
primary disease

- Initial treatment may have included intraperitoneal therapy, high-dose therapy,
consolidation therapy, non-cytotoxic therapy, or extended therapy administered
after surgical or non-surgical assessment

- No additional cytotoxic chemotherapy for management of recurrent or persistent
disease, including re-treatment with initial chemotherapy regimens

- One additional non-cytotoxic regimen for management of recurrent or
persistent disease allowed

- Must be considered platinum-resistant or refractory according to standard GOG
criteria (i.e., treatment-free interval of < 6 months after completion of
platinum-based therapy OR progressed during platinum-based therapy)

- Not eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mcL

- Platelet count ≥ 100,000/mcL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- LDH levels ≤ 0.8 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No neuropathy (sensory and motor) > grade 1 by CTCAE criteria

- No active infection requiring antibiotics, except uncomplicated urinary tract
infection

- No other invasive malignancies within the past 5 years, except nonmelanoma skin
cancer or other specific malignancies

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior surgery, radiotherapy, or chemotherapy

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- At least 3 weeks since prior biological therapy, immunotherapy, or other therapy
directed at the malignant tumor

- No prior radiotherapy to > 25% of marrow-bearing areas

- No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for
the treatment of ovarian, fallopian tube, or primary peritoneal cancer

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin
allowed provided it was completed > 3 years ago and the patient remains free of
recurrent or metastatic disease

- No prior chemotherapy for any abdominal or pelvic tumor, except for the treatment of
ovarian, fallopian tube, or primary peritoneal cancer

- Prior adjuvant chemotherapy for localized breast cancer allowed provided it was
completed > 3 years ago and the patient remains free of recurrent or metastatic
disease

- No prior elesclomol sodium

- No prior second-line cytotoxic chemotherapy

- No prior cancer treatment that would contraindicate study therapy

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

Bradley J. Monk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000641202

NCT ID:

NCT00888615

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cavity cancer
  • ovarian serous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • ovarian mixed epithelial carcinoma
  • Brenner tumor
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Avera Cancer InstituteSioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
Rush University Medical CenterChicago, Illinois  60612-3824
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
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
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
McFarland Clinic, PCAmes, Iowa  50010
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Seattle Cancer Care AllianceSeattle, Washington  98109
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Duke Cancer InstituteDurham, North Carolina  27710
Pacific Gynecology SpecialistsSeattle, Washington  98104
Gynecologic OncologyHinsdale, Illinois  60521
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Northwest Hospital and Medical CenterSeattle, Washington  98133
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
St. Mary Regional Cancer Center at St. Mary Medical CenterWalla Walla, Washington  99362
Lyndon B. Johnson General HospitalHouston, Texas  77026-1967
St. Vincent Oncology CenterIndianapolis, Indiana  46260