A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Completed · Phase 2

Conditions studied: Fallopian Tube Carcinoma, Malignant Ovarian Mixed Epithelial Tumor, Ovarian Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma, Undifferentiated Ovarian Carcinoma

In brief

This phase II trial is studying the side effects and how well A6 works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. A6 may stop the growth of tumor cells by blocking blood flow to the tumor.

Key facts

Study ID

NCT00939809

Run by

Gynecologic Oncology Group

People needed

31

Starts

2009-07-01

Last updated by the study team

2019-01-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed persistent or recurrent 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 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must have ≥ 1 target lesion to assess response as defined by RECIST criteria
• Tumors within a previously irradiated field are designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence of disease ≥ 90 days following completion of radiotherapy
• Must not be eligible for a higher priority GOG clinical trial, if one exists (i.e., any active GOG Phase III clinical trial for the same patient population)
• Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
• Initial treatment may have included high-dose therapy, consolidation therapy, non-cytotoxic therapy, or extended therapy administered after surgical or non-surgical assessment
• One additional cytotoxic regimen for management of recurrent or persistent disease allowed
• Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease) must have a platinum-free interval of < 12 months, have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
• GOG performance status 0-2 (for patients who received 1 prior regimen) OR 0-1 (for patients who received 2 prior regimens)
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Where it is running

• Georgia Regents University Medical Center — Augusta, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Cancer Center/Fairview Hospital — Cleveland, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Hillcrest Hospital Cancer Center — Mayfield Heights, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
• Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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