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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
Not Enrolling
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)



- 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.


- 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


- 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


- 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

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


- 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

- No prior elesclomol sodium

- No prior second-line cytotoxic chemotherapy

- No prior cancer treatment that would contraindicate study therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Safety Issue:


Principal Investigator

Bradley J. Monk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Federal Government

Study ID:




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



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