Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: LDFWART With Docetaxel in Patients With Platinum-Resistant 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: 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.

Relevance to patient case: not relevant