ldfwart with docetaxel in patients with platinum-resistant recurrent ovarian carcinoma

Conditions: Ovarian Cancer; Ovarian Carcinoma; Recurrent Ovarian Cancer; Recurrent Ovarian Carcinoma

Summary: the ultimate clinical aim of this proposed phase i trial is to evaluate the toxicity and determine the recommended phase ii dose of combining the effect of ldfwart following administration of docetaxel for 6 cycles in patients with recurrent platinum-resistant ovarian cancer.


Eligibility criteria:
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 \ 80 yrs. of age.

Keywords: low dose fractionated whole abdominal radiation therapy ldfwart docetaxel ovarian cancer ovarian carcinoma platinum-resistant