Doxil and Gemcitabine in Recurrent Ovarian Cancer

A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00312650

Enrollment

Registered

2006-04-10

Start date

2006-04-30

Completion date

2006-05-31

Last updated

2015-01-12

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

Conditions

Ovarian Carcinoma

Keywords

ovarian cancer, recurrent, progressive

Brief summary

Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study investigates using a lower dose given more frequently in combination with a second drug Gemcitabine.

Detailed description

This study will evaluate the toxicities of Doxil and Gemcitabine given on an every two week basis. Our hypothesis is that toxicity will be less than that with standard dosing without any negative effect on survival. Patients will also be evaluated with CT scans every 3 months. Toxicity will be assessed with every cycle of treatment. Treatment will continue until toxicity or signs of progression.

Interventions

DRUGliposomal doxorubicin and gemcitabine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* recurrent platinum resistant ovarian cancer * measurable disease

Exclusion criteria

* prior treatment with Doxil or Gemzar * life expectancy \<3months * cardiac ejection fraction \<50%

Design outcomes

Primary

Measure	Time frame
rate of hand-foot syndrome	—

Secondary

Measure	Time frame
objective response rate	—

Countries

United States

Outcome results

None listed

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