Ovarian CancerPhase 1/2NCT00562185
Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer
A Phase 1/2 study testing carboplatin and doxorubicin hydrochloride in people with Ovarian Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin together with carboplatin may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- carboplatin and doxorubicin hydrochloride
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2009
- Phase
- Phase 1/2
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GOG performance status 0, 1, or 2
- Life expectancy > 6 months
- Absolute neutrophil count ≥ 1,500/uL
- Platelet count ≥ 100,000/uL
- Hemoglobin > 9.0 g/dL
- Creatinine ≤ 2.0 mg/dL
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- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- SGOT and alkaline phosphatase ≤ 3 x ULN
- Neuropathy (sensory and motor) ≤ CTCAE grade 1
- See Disease Characteristics
- At least 6 months since prior adjuvant regimen
- At least 4 weeks since prior salvage treatment
- May have received secondary cytoreduction for recurrent ovarian cancer
- May have received prior intraperitoneal therapy for ovarian cancer
- May have received no more than 2 prior platinum and taxane-based regimens
- May have received prior intraperitoneal platinum during front-line treatment
Who cannot join
- GOG performance status 3 or 4
- Pregnant or breastfeeding
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of DOXIL®
- Abnormal LVEF as determined by gated cardiac radionucleotide scan (MUGA)
- Septicemia or severe infection
- Acute hepatitis or severe gastrointestinal bleeding
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- Any of the following:
- Unstable angina
- Myocardial infarction within the past 6 months
- NYHA class II-IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Clinically significant pericardial disease
- Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months
- Other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Prior anthracycline dose exceeding 360 mg/m^2 for doxorubicin hydrochloride (including DOXIL®) or 720 mg/m^2 for epirubicin hydrochloride
- Prior radiotherapy
- Prior intraperitoneal carboplatin or cisplatin as salvage treatment for recurrent ovarian cancer
- Concurrent amifostine or other protective agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
Official title: A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.
PURPOSE: This phase I and phase II trial is studying the side effects and best dose of carboplatin when given together with doxorubicin to see how well it works in treating patients with recurrent ovarian cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose and safety of intravenous doxorubicin hydrochloride and intraperitoneal carboplatin in patients with platinum-sensitive recurrent ovarian cancer.
- To evaluate the feasibility of this regimen in these patients.
Secondary
- To evaluate the response rate and progression-free survival of patients with recurrent ovarian cancer who have had no more than two prior salvage regimens.
OUTLINE: This is a phase I dose-escalation study of carboplatin followed by a phase II study.
- Phase I: Patients receive doxorubicin hydrochloride IV over 1 hour followed by carboplatin intraperitoneally on day 1 until the maximum tolerated dose is achieved. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Phase II: Patients receive doxorubicin hydrochloride as in phase I and carboplatin at the maximum tolerated dose as in phase I.
After completion of study treatment, patients are followed every 4 weeks for 1 year.
PROJECTED ACCRUAL: A total of 61 patients (18 patients in phase I and 43 patients in phase II) will be accrued for this study.
- Conditions
- Ovarian Cancer
- Being tested
- carboplatin, doxorubicin hydrochloride
- Keywords
- recurrent ovarian epithelial cancer, ovarian sarcoma, recurrent ovarian germ cell tumor, ovarian stromal cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I)
Primary efficacy and safety (phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Funding source withdrew funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Jayanthi S. Lea, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562185
- Sponsor's protocol ID
- CDR0000574034
- Other IDs
- SCCC-04E07, SCCC-062007-043, ORTHO-SCCC-04E07
- Status last verified
- Oct 2017
- First submitted
- 20 Nov 2007
- Last updated
- 20 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00562185
- Acronym / sponsor ID
- CDR0000574034
- Conditions
- Ovarian Cancer
- Keywords
- recurrent ovarian epithelial cancer, ovarian sarcoma, recurrent ovarian germ cell tumor, ovarian stromal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding source withdrew funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C.
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Nov 2007 (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.
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.
PURPOSE: This phase I and phase II trial is studying the side effects and best dose of carboplatin when given together with doxorubicin to see how well it works in treating patients with recurrent ovarian cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose and safety of intravenous doxorubicin hydrochloride and intraperitoneal carboplatin in patients with platinum-sensitive recurrent ovarian cancer.
- To evaluate the feasibility of this regimen in these patients.
Secondary
- To evaluate the response rate and progression-free survival of patients with recurrent ovarian cancer who have had no more than two prior salvage regimens.
OUTLINE: This is a phase I dose-escalation study of carboplatin followed by a phase II study.
- Phase I: Patients receive doxorubicin hydrochloride IV over 1 hour followed by carboplatin intraperitoneally on day 1 until the maximum tolerated dose is achieved. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Phase II: Patients receive doxorubicin hydrochloride as in phase I and carboplatin at the maximum tolerated dose as in phase I.
After completion of study treatment, patients are followed every 4 weeks for 1 year.
PROJECTED ACCRUAL: A total of 61 patients (18 patients in phase I and 43 patients in phase II) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- GOG performance status 0, 1, or 2
- Life expectancy > 6 months
- Absolute neutrophil count ≥ 1,500/uL
- Platelet count ≥ 100,000/uL
- Hemoglobin > 9.0 g/dL
Key exclusion criteria (21 listed)
- GOG performance status 3 or 4
- Pregnant or breastfeeding
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of DOXIL®
- Abnormal LVEF as determined by gated cardiac radionucleotide scan (MUGA)
- Septicemia or severe infection
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 |
|---|---|---|
| carboplatin | Drug | – |
| doxorubicin hydrochloride | Drug | – |
Primary outcome
Acute toxicity
Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I)
Primary efficacy and safety (phase II)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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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.
Jayanthi S. Lea, MD study chair
Simmons 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 1/2 study testing carboplatin and doxorubicin hydrochloride in people with Ovarian Cancer, run by University of Texas Southwestern Medical Center 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 16 inclusion and 21 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: withdrawn, as of the sponsor's last update on 20 Nov 2017. 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 combined 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Acute toxicity. The study lists 3 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 20 Nov 2017.