Phase 2
Completed N=29
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
Primary Peritoneal Cavity Cancer · Ovarian Cancer
Source: ClinicalTrials.gov NCT00093496 ↗
Enrolled (actual)
29
Serious AEs
34.5%
Results posted
Jul 2013
Primary outcomePrimary: Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. — 0.071; 0; 0; 0 proportion of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. |
0.071; 0; 0; 0 | — |
| SECONDARY Times to Progression |
1.6; 2.7 | — |
| SECONDARY Overall Survival |
18.3; 11.5 | — |
| SECONDARY Toxicity |
9; 7; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
- Poorly controlled angina
- No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No history of QTc ≥ 500 msec
- No active ischemic heart disease within the past 12 months
- No congenital long QT syndrome
- No left bundle branch block
- No cardiac symptoms ≥ grade 2
- No history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
- Does not meet the medicare criteria for home oxygen
- No pulse oximetry at rest and exercise 25% of bone marrow
- No history of radiotherapy that potentially included the heart in the field (e.g., mantle)
- Chest wall irradiation or other radiotherapy techniques that do not include the heart in the radiation field area allowed
- More than 4 weeks since prior radiotherapy
- More than 4 weeks since prior radiopharmaceuticals
- No concurrent radiotherapy
- No other concurrent investigational therapy
- No concurrent medications that may prolong QTc
Data sourced from ClinicalTrials.gov (NCT00093496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.