CancerPhase 1NCT00183742
Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)
A Phase 1 study testing liposomal doxorubicin and docetaxel in people with Cancer and Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This study is for patients with advanced cancer that has failed treatment with conventional therapy or for which no standard treatment exists. The purpose of this study is to determine the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called Taxotere) and liposomal doxorubicin (also called… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- liposomal doxorubicin and docetaxel
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to May 2006
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proof of advanced or recurrent solid tumor which has failed prior therapy, or for which no effective therapy is available.
- Ovarian cancer patients (or primary peritoneal carcinoma) whose only manifestation of disease is an elevated cancer antigen (CA) 125 of > 100 are eligible.
- SWOG performance status 0-2.
- Absolute granulocyte count (AGC) greater than or equal to 1.5; platelets greater than or equal to 100,000.
- Total bilirubin less than or equal to the upper limit of normal (ULN).
- Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is <= ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are <= ULN. However, patients who have both transaminase elevation > 1.5 x ULN and alkaline phosphatase > 2.5 x ULN are not eligible for this study (due to decreased clearance of docetaxel and increased risk of toxicity).
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- Age greater than or equal to 18 years.
- Fully recovered from acute toxicities from chemotherapy, radiation, or surgery.
- Negative serum pregnancy test, if patient is female, still fertile, and sexually active.
Who cannot join
- Prior treatment with Doxil or weekly docetaxel. Prior docetaxel administered every 3 weeks is allowed.
- Evidence of moderate peripheral neuropathy greater than or equal to grade 2.
- Medical, social, or psychological factors interfering with compliance.
- Known history of cardiac disease (congestive heart failure, coronary artery disease) that would preclude treatment with Doxil in the opinion of the investigator.
- Cardiac ejection fraction < 50%
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase I Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)
This study is for patients with advanced cancer that has failed treatment with conventional therapy or for which no standard treatment exists. The purpose of this study is to determine the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called Taxotere) and liposomal doxorubicin (also called Doxil), when given together and to determine the side effects of this combination. Both Taxotere and Doxil are chemotherapy drugs that can decrease the size of several different tumors. Taxotere is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancers, and Doxil is approved for the treatment of ovarian cancer.
- Being tested
- liposomal doxorubicin and docetaxel
- Keywords
- Phase 1, Phase I, Phase one, Solid tumor
- Medical subject headings
- Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal doxorubicin and docetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) of liposomal doxorubicin (Doxil) administered every 4 weeks or every 2 weeks in combination with docetaxel (Taxotere) administered on a weekly schedule
To establish the toxicity profile of this combination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2000
- Primary completionOct 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Responsible party
- Sponsor
- Investigators
- Syma Iqbal, M.D., Principal investigator, U.S.C./Norris Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183742
- Sponsor's protocol ID
- 0C-00-6
- Status last verified
- May 2014
- First submitted
- 9 Sep 2005
- Last updated
- 22 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)
- ClinicalTrials.gov ID
- NCT00183742
- Acronym / sponsor ID
- 0C-00-6
- Keywords
- Phase 1, Phase I, Phase one, Solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Study start
- Dec 2000
- Primary completion
- Oct 2005 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 16 Sep 2005 (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.
This study is for patients with advanced cancer that has failed treatment with conventional therapy or for which no standard treatment exists. The purpose of this study is to determine the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called Taxotere) and liposomal doxorubicin (also called Doxil), when given together and to determine the side effects of this combination. Both Taxotere and Doxil are chemotherapy drugs that can decrease the size of several different tumors. Taxotere is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancers, and Doxil is approved for the treatment of ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological proof of advanced or recurrent solid tumor which has failed prior therapy, or for which no effective therapy is available.
- Ovarian cancer patients (or primary peritoneal carcinoma) whose only manifestation of disease is an elevated cancer antigen (CA) 125 of > 100 are eligible.
- SWOG performance status 0-2.
- Absolute granulocyte count (AGC) greater than or equal to 1.5; platelets greater than or equal to 100,000.
- Total bilirubin less than or equal to the upper limit of normal (ULN).
Key exclusion criteria (6 listed)
- Prior treatment with Doxil or weekly docetaxel. Prior docetaxel administered every 3 weeks is allowed.
- Evidence of moderate peripheral neuropathy greater than or equal to grade 2.
- Medical, social, or psychological factors interfering with compliance.
- Known history of cardiac disease (congestive heart failure, coronary artery disease) that would preclude treatment with Doxil in the opinion of the investigator.
- 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 docetaxel | Drug | – |
Primary outcome
To determine the maximum tolerated dose (MTD) of liposomal doxorubicin (Doxil) administered every 4 weeks or every 2 weeks in combination with docetaxel (Taxotere) administered on a weekly schedule
To establish the toxicity profile of this combination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
Syma Iqbal, M.D. principal investigator
U.S.C./Norris Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing liposomal doxorubicin and docetaxel in people with Cancer and Carcinoma, run by University of Southern California 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 22 May 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerated dose (MTD) of liposomal doxorubicin (Doxil) administered every 4 weeks or every 2 weeks in combination with docetaxel (Taxotere) administered on a weekly schedule. The study lists 2 primary outcomes in all. 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 22 May 2014.