CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Completed · Phase 2
Conditions studied: Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma
In brief
Phase II trial to study the effectiveness of CT-2103 in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Key facts
- Study ID
- NCT00045682
- Run by
- Gynecologic Oncology Group
- People needed
- 78
- Starts
- 2002-09-01
- Last updated by the study team
- 2017-07-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer after second-line therapy
- Received 1 prior platinum-based first-line chemotherapy regimen and 1 prior second-line (non-platinum, non-taxane) chemotherapy regimen
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- At least 1 target lesion that has not previously been irradiated
- Ineligible for a higher priority GOG protocol (if one exists)
- Ineligible for the currently active phase II cytotoxic protocol for platinum-resistant disease
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- No active bleeding
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- PT or PTT less than ULN
- Creatinine no greater than 1.5 times ULN
- No uncontrolled hypertension
- No uncompensated congestive heart failure
- No symptomatic coronary artery disease
- No myocardial infarction within the past 6 months
- No sensory or motor neuropathy greater than grade 1
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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