3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal 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

Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer

Key facts

Study ID

NCT00081276

Run by

National Cancer Institute (NCI)

People needed

48

Starts

2005-07-01

Last updated by the study team

2013-01-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed ovarian epithelial or primary peritoneal cancer
• Recurrent or persistent disease
• At least 1 unidimensionally measurable target lesion
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Outside a previously irradiated field
• Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease
• Initial treatment may have included high-dose, consolidation, or extended therapy after surgical or non-surgical assessment
• Considered platinum resistant or refractory, according to 1 of the following criteria:
• Treatment-free interval of less than 6 months after platinum-based therapy
• Disease progression during platinum-based therapy
• Ineligible for any higher priority GOG protocol
• Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen)
• Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens)
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN
• No serious cardiac disease
• No prior myocardial infarction
• No uncontrolled congestive heart failure
• No pulmonary disease requiring oxygen
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.