Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer

Completed · Phase 2

Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

In brief

Phase II trial to study the effectiveness of irofulven 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

NCT00053365

Run by

National Cancer Institute (NCI)

People needed

61

Starts

2003-06-01

Expected to finish

2010-07-01

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
• Recurrent or persistent disease
• At least 1 unidimensionally measurable target lesion* defined as:
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease
• Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
• Patients who have not received prior paclitaxel may receive a second regimen containing paclitaxel
• Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
• Platinum-sensitive disease
• Platinum-free interval** of more than 6 months, but less than 12 months duration, with no clinical evidence of progressive disease after response to platinum
• Performance status - GOG 0-2 for patients who received 1 prior therapy regimen
• Performance status - GOG 0-1 for patients who received 2 prior therapy regimens
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• 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
• Creatinine normal
• Creatinine clearance at least 60 mL/min
• No prior congestive heart failure requiring medication
• No uncontrolled hypertension within the past 6 months
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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