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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 Center Seattle, Washington  98109
University of Chicago Cancer Research Center Chicago, Illinois  60637
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
Avera Cancer Institute Sioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
St. Joseph's Hospital and Medical Center Phoenix, Arizona  85001-2071
Rush University Medical Center Chicago, Illinois  60612-3824
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Helen and Harry Gray Cancer Center at Hartford Hospital Hartford, Connecticut  06102-5037
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
John Muir/Mt. Diablo Comprehensive Cancer Center Walnut Creek, California  94598
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
McFarland Clinic, PC Ames, Iowa  50010
Greater Baltimore Medical Center Cancer Center Baltimore, Maryland  21204
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Seattle Cancer Care Alliance Seattle, Washington  98109
Union Hospital of Cecil County Elkton MD, Maryland  21921
Duke Cancer Institute Durham, North Carolina  27710
Pacific Gynecology Specialists Seattle, Washington  98104
Gynecologic Oncology Hinsdale, Illinois  60521
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Northwest Hospital and Medical Center Seattle, Washington  98133
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
St. Mary Regional Cancer Center at St. Mary Medical Center Walla Walla, Washington  99362
Lyndon B. Johnson General Hospital Houston, Texas  77026-1967
St. Vincent Oncology Center Indianapolis, Indiana  46260