Status:
WITHDRAWN
Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca
Lead Sponsor:
Mark Dewhirst
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-72 years
Phase:
NA
Brief Summary
This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) pl...
Detailed Description
Day 1 of each 21 day Cycle: Paclitaxel 175 mg/m2 IV (infused over 3 hours) Day 1 or 2 of each Cycle Adequate IV hydration with normal saline (1000 ml recommended)followed by intraperitoneal infusion...
Eligibility Criteria
Inclusion
- Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Optimal debulking (\< 1cm residual disease) of their disease within 6 weeks of the start of the study
- Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy
- GOG performance status 0, 1, or 2
- Patients must have normal organ and marrow function defined as:
- absolute neutrophil count \>1,500/mcL
- platelets \>100,000/mcL
- total bilirubin and creatinine \<1.5 X institutional upper limit of normal(ULN)
- AST(SGOT)/ALT(SGPT)\<3 X institutional ULN
Exclusion
- Patients with biochemical recurrences or evidence of measurable disease
- Patients with suboptimal (\>1 cm) residual disease
- Patients who have had chemotherapy within 4 weeks prior
- Receiving any investigational agents
- Known brain metastases
- Epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
- Uncontrolled intercurrent illness
- Prior radiation therapy
- History of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00787488
Start Date
April 1 2009
End Date
April 1 2009
Last Update
November 11 2014
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