Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT01003938
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a single arm phase II study with a combination of Hycamptin® (topotecan) and erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30 patients will be enrolled in this study.

Key Dates

First listed
Oct 29, 2009
Start date
Aug 31, 2009
Status verified
May 2016
Primary completion
Sep 30, 2012
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: topotecan and erlotinib
    Topotecan 0.4 mg/m\^2/day administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle; erlotinib 150 mg daily for 9 days every 21 days cycle. Both drugs will be given for a minimum of 2 cycles.

Primary Outcome Measure

CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib [ Time Frame: Up to 3 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Bellevue Hospital CenterNew YorkNew York10016-
NYU Clinical Cancer CenterNew YorkNew York10016-
Tisch HospitalNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Bellevue Hospital Center· New York, NYNYU Clinical Cancer Center· New York, NYTisch Hospital· New York, NY

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