A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: 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
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Endometrioid; Cystadenocarcinoma; Cystadenocarcinoma, Serous; Cystadenocarcinoma, Mucinous; Brenner Tumor; Recurrence
Intervention: Urokinase-Derived Peptide A6; Laboratory Biomarker Analysis
Intervention description: Given SC; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able and willing to self-administer daily subcutaneous (SC) injections or has a
             caregiver who is willing and able to administer daily SC injections

          -  No active infection requiring antibiotics, except uncomplicated urinary tract
             infection

          -  No neuropathy (sensory and motor) > grade 2, according to CTCAE v3.0

          -  No other invasive malignancies within the past 5 years, except for non-melanoma skin
             cancer

          -  No history of sensitivity to A6

          -  No active gastrointestinal bleeding within the past month

          -  No other disease that, in the opinion of the investigator, could jeopardize patient
             safety or interfere with study objectives

          -  No concurrent amifostine or other protective reagents

          -  Recovered from prior surgery, radiotherapy, or chemotherapy

          -  No prior non-cytotoxic therapy for management of recurrent or persistent disease

               -  Prior biologic (non-cytotoxic) therapy as part of primary treatment regimen
                  allowed

          -  At least 1 week since prior hormonal therapy directed at the malignant tumor

          -  At least 3 weeks since any other prior therapy directed at the malignant tumor,
             including immunological agents

          -  More than 2 weeks since prior major surgical procedure

          -  More than 5 years since prior radiotherapy to any portion of the abdominal cavity or
             pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal
             cancer

          -  More than 3 years since prior radiotherapy for localized cancer of the breast, head
             and neck, or skin AND remains free of recurrent or metastatic disease

               -  Patients with ductal breast carcinoma in situ may have undergone localized
                  radiotherapy within the past 3 years

          -  More than 5 years since prior chemotherapy for any abdominal or pelvic tumor other
             than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

          -  More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND
             remains free of recurrent or metastatic disease

          -  More than 30 days since prior investigational drugs

          -  No prior A6

          -  No prior radiotherapy to > 25% of marrow-bearing areas

          -  No prior cancer treatment that would contraindicate study therapy