LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma

Inclusion Criteria:

- 1. Patients must have platinum-resistant disease relapsing within 6 months or less
from the date of their last cycle of initial adjuvant chemotherapy recurrent
adenocarcinoma from a primary ovarian, tubal, or peritoneal cancer following
first-line chemotherapy for metastatic disease. There is no limit on prior number of
chemotherapy regimens. Patients who have received prior systemic docetaxel and
platinum-based chemotherapy are eligible

- 1.1 Patients must have ≥ 1cm measurable disease on imaging studies independent of
patients having an optional surgical salvage procedure.

- 2. Patients must have a life expectancy of at least 6 months.

- 3. Patients must have Karnofsky performance status of ≥ 60 or Gynecology Oncology
(GOG) performance status of ≤ 2 (see www.GOG.org website).

- 4. Age 18 - 80 years old

- 5. Patients must have an adequate bone marrow, renal, and hepatic function:

- 5.1 WBC: ≥ 3,000 /mcl

- 5.2 ANC: ≥ 1,500 /mcl

- 5.3 Platelets: ≥ 100,000 /mcl

- 5.4 Creatinine: < 2.0 mg/dcl

- 5.5 Bilirubin: < 1.5x institutional normal value

- 5.6 LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:< 3x institutional normal
value.

- 6. Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- 1. Patients who have received prior radiotherapy to the chest, whole abdomen, or
lower extremities above the knees.

- 2. Patients who have received prior radiation therapy to the head, neck, or lower
extremities below the knees if greater than 3 years prior to study entry.

- 3. Evidence of extra-abdominal extension of disease (such as groin nodes, lung,
supraclavicular nodes, and pleural fluid).

- 4. Patients may not be receiving any other investigational agents within 4 weeks
preceding the start of study treatment) or chemotherapy for at least 3 weeks
preceding the start of study treatment.

- 5. Patients who have been diagnosed with another prior malignant tumor within 3 years
of study entry, excluding non-melanoma skin cancer and carcinoma in situ of the
cervix.

- 6. Patients with prior history of a severe hypersensitivity reaction to paclitaxel
(polysorbate 80-Cremophor).

- 7. Patients with current history of uncontrolled hypertension, angina pectoris, heart
failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active
infection.

- 8. Presence of any medical condition that in the opinion of the investigator deems
the patient unable to participate.

- 9. Females of child-bearing potential. It is expected that ovarian cancer patients
would have had a hysterectomy and/or oophorectomy as part of the original standard of
care.

- 10. Patients that are < 18 yrs. of age or > 80 yrs. of age.