Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02121990
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to test the safety of the drug olaparib at different dose levels. It will be given with the standard initial chemotherapy for cancer as well as a drug called bevacizumab.

Key Dates

Start date
Apr 21, 2014
Status verified
Aug 2020
Primary completion
Aug 19, 2020
Completion
Aug 19, 2020

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cisplatin, Paclitaxel, bevacizumab & olaparib
    All treatments will be given in the outpatient setting. A cycle is 21 days. The sequence of infusions on Day 1 will be IV paclitaxel (135 mg/m2), then IV bevacizumab (15 mg/kg, beginning Cycle 2). On Day 2 patients will receive IP cisplatin (75 mg/m2). Patients will be given twice-daily treatment with oral olaparib in cycles 1-6 for 7 consecutive days, starting on Day 2 (Days 2-8). IP paclitaxel (60 mg/m2) will be given on Day 8. Sequential cohorts of 3 patients will receive escalating doses of olaparib (50mg BID, 100mg BID, 200mg BID).

Primary Outcome Measure

maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center at Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering Cancer Center at Mercy Medical CenterRockville CentreNew York11570-

Find similar trials in Basking Ridge, NJ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Memorial Sloan Kettering Cancer Center at Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYMemorial Sloan Kettering Cancer Center at Mercy Medical Center· Rockville Centre, NY

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