Ovarian CarcinomaPhase 2NCT00312650
Doxil and Gemcitabine in Recurrent Ovarian Cancer
A Phase 2 study testing liposomal doxorubicin and gemcitabine in people with Ovarian Carcinoma, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- liposomal doxorubicin and gemcitabine
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recurrent platinum resistant ovarian cancer
- measurable disease
Who cannot join
- prior treatment with Doxil or Gemzar
- life expectancy <3months
- cardiac ejection fraction <50%
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants' Hospital
Providence, Rhode Island, 02905
About this study
Official title: A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
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.
Read the 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.
- Conditions
- Ovarian Carcinoma
- Being tested
- liposomal doxorubicin and gemcitabine
- Keywords
- ovarian cancer, recurrent, progressive
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal doxorubicin and gemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of hand-foot syndrome
Secondary outcomes (1)
objective response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Investigators
- Paul A DiSilvestro, MD, Principal investigator, Program in Women's Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312650
- Sponsor's protocol ID
- 05-0120
- Status last verified
- Jan 2015
- First submitted
- 6 Apr 2006
- Last updated
- 12 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00312650
- Acronym / sponsor ID
- 05-0120
- Conditions
- Ovarian Carcinoma
- Keywords
- ovarian cancer, recurrent, progressive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- Apr 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 10 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- recurrent platinum resistant ovarian cancer
- measurable disease
Key exclusion criteria (3 listed)
- prior treatment with Doxil or Gemzar
- life expectancy <3months
- cardiac ejection fraction <50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal doxorubicin and gemcitabine | Drug | – |
Primary outcome
rate of hand-foot syndrome
1 secondary outcome
objective response rate
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A DiSilvestro, MD principal investigator
Program in Women's Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liposomal doxorubicin and gemcitabine in people with Ovarian Carcinoma, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of hand-foot syndrome. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.