A Phase II Evaluation of a Urokinase-Derived Peptide (A6) (IND #64,298) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- 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

- No concurrent amifostine or other protective reagents