Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
Completed · Phase 2
Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer
In brief
Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die.
Key facts
- Study ID
- NCT00093496
- Run by
- National Cancer Institute (NCI)
- People needed
- 29
- Starts
- 2007-10-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2014-05-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of ovarian epithelial or primary peritoneal cavity cancer
- Relapsed disease
- Persistent disease
- Platinum-resistant disease, defined as having evidence of disease that would be expected to be non-responsive to additional platinum-containing regimens or contraindication to platinum-based chemotherapy and 1 of the following:
- Failure to obtain a complete response to initial platinum therapy
- Recurrence < 6 months after completing a platinum-containing regimen for initial or recurrent disease
- Any of the above situations and following treatment with additional chemotherapy regimens (e.g., non-platinum containing regimens)
- Relative or absolute contraindication to platinum-based chemotherapy regimens (e.g., platinum allergy) as determine by the investigator
- Measurable or evaluable disease
- Patients with a rising CA 125 level, even in the absence of other indicators of disease, allowed provided CA 125 is ≥ 2 times upper limit of normal (ULN)
- Patients with accessible disease must be willing to undergo tumor biopsies
- No CNS metastases
- Performance status - ECOG 0-2
- WBC ≥ 3,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Bilirubin normal
- Alkaline phosphatase ≤ 2.5 times ULN
- AST ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Ejection fraction > 40% by ECHO for patients with prior anthracycline therapy
- No significant cardiac disease including any of the following:
- New York Heart Association class III or IV heart disease
- History of myocardial infraction within the past year
- Uncontrolled dysrhythmias or requirement for antiarrhythmic drugs
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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