Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer

An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00061308

Enrollment

Registered

2003-05-28

Start date

2002-12-31

Completion date

Unknown

Last updated

2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Neoplasms, Ovarian, Ovarian Cancer, Peritoneal Cancer

Keywords

Ovarian cancer, peritoneal cancer, cancer, Fallopian cancer

Brief summary

This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment. Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.

Interventions

DRUGTopotecan

DRUGGemcitabine

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease. * At least 4 weeks since last surgery or radiation therapy. * Must have had a treatment-free interval of greater than 6 months following response to platinum. * ECOG performance status of 0,1, or 2.

Exclusion criteria

* Women of child-bearing potential that do not practice adequate contraception. * Pregnant or lactating. * Received more than one primary chemotherapy regimen. * Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years. * Active uncontrolled infection requiring antibiotics. * Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study. * Received radiation to more than 10% of bone. * Prior treatment with topotecan or gemcitabine. * Hypersensitivity to camptothecin or nucleoside analogues. * Use of an investigational agent within 30 days.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
response duration time to response time to progression survival safety	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026