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SCCA Gynecologic Cancer Clinical Trials

Elesclomol Sodium and Paclitaxel for Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer (GOG 0260)
A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Status Conditions Phase Study ID
Closed Fallopian Cancer
Ovarian Cancer
Primary Peritoneal Cancer (PPC)
Phase II GOG 0260
NCT00888615
Summary

RATIONALE: Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving elesclomol together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving elesclomol sodium together with paclitaxel and to see how well it works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


Investigator
Benjamin Greer, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Group Health 206-225-7893  
Eligibility Criteria (must meet the following to participate in this study)

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
Last Updated
May 25, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.