Oxaliplatin and Topotecan in Advance Ovarian Cancer

Stopped early · Phase 2

Conditions studied: Recurrent Ovarian Epithelial Cancer

In brief

This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Key facts

Study ID

NCT00313612

Run by

National Cancer Institute (NCI)

People needed

39

Starts

2006-01-01

Expected to finish

2012-12-01

Last updated by the study team

2015-11-27

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
• Meets 1 of the following criteria for response to prior platinum-based therapy:
• Platinum-resistant disease, defined as a disease-free interval of < 6 months after prior platinum-based therapy OR progressive disease on a platinum-containing regimen
• Platinum-sensitive disease, defined as a disease-free interval of > 6 months after prior platinum-based therapy
• Measurable or evaluable disease: Measurable disease is characterized as lesions reproducibly measurable in 1 dimension; evaluable disease is defined as known disease with CA125 levels > 50 U/mL on 2 occasions >= 1 week apart
• Previously treated with a taxane and platinum-based regimen, only 1 prior platinum-based regimen, including IV or intraperitoneal consolidation, one additional non-platinum and non-topotecan chemotherapy regimen allowed
• Life expectancy >= 4 months
• Total bilirubin =< 1.5 times upper limit of normal (ULN)
• AST =< 2.5 times ULN (5 times ULN if liver metastases are present)
• Creatinine =< 1.5 times ULN AND creatinine clearance > 40 mg/dL

You may not qualify if…

• No presence of any other active cancer
• No uncontrolled intercurrent illness, including the following:
• Infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• No history of severe allergy to platinum compounds
• (Mild reaction (skin only) allowed provided a negative skin test is obtained)
• No history of allergic reaction to appropriate antiemetics (e.g., 5HT3 antagonists)
• Recovered from prior chemotherapy
• At least 2 weeks since prior radiotherapy and recovered
• At least 4 weeks since prior investigational drugs
• No prior radiotherapy to the whole pelvic field
• No unresolved sequelae resulting from any surgical procedures
• No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during topotecan infusion
• No concurrent participation in another investigational trial
• No other concurrent investigational agents
• No other concurrent anticancer therapy

Where it is running

• NYU Cancer Institute — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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