Fallopian Tube CancerPhase 1NCT00006235
Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 1 study testing carboplatin and pegylated liposomal doxorubicin hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by Gynecologic Oncology Group.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin and carboplatin in treating patients who have recurrent… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- carboplatin and pegylated liposomal doxorubicin hydrochloride
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven recurrent ovarian, tubal, or peritoneal cancer that is platinum sensitive (i.e., 6 months from last chemotherapy) Maximum of 1 prior chemotherapy regimen comprised of no more than 6 treatments at first recurrence Must have 1 of the following epithelial subtypes: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell Malignant Brenner tumor Adenocarcinoma not otherwise specified Measurable or evaluable disease Greater than 2 cm by CT scan, if measurable
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin normal SGOT, SGPT, GGT, and alkaline phosphatase no greater than 2.5 times upper limit of normal No acute hepatitis Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF normal by MUGA No congestive heart failure No unstable angina No myocardial infarction within the past 6 months Abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if disease has been stable for at least 6 months Other: No septicemia or significant infection No severe gastrointestinal bleeding No other malignancy within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior anthracycline therapy At least 3 weeks since other prior chemotherapy for ovarian, fallopian tube, or peritoneal cancer and recovered Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: At least 3 weeks since prior surgery for ovarian, fallopian tube, or peritoneal cancer and recovered Other: No other prior cancer therapy that would preclude study therapy
About this study
Official title: A Phase I Trial of Combination Carboplatin and Lipsomal Doxorubicin (Doxil) In Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of doxorubicin HCl liposome (Doxil) when combined with carboplatin in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the rate of response in patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study of doxorubicin HCl liposome (Doxil). Patients receive Doxil IV over 1 hour and carboplatin IV on day 1. Treatment continues every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of Doxil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 0 or 1 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter until recurrence or death.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study over 1 year.
- Being tested
- carboplatin, pegylated liposomal doxorubicin hydrochloride
- Keywords
- recurrent ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, fallopian tube cancer, primary peritoneal cavity cancer, Brenner tumor
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Brenner Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
pegylated liposomal doxorubicin hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2004 (estimated)
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael Rodriguez, MD, Study chair, University Hospitals Seidman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006235
- Sponsor's protocol ID
- CDR0000068160
- Other IDs
- GOG-9909
- Status last verified
- Feb 2006
- First submitted
- 11 Sep 2000
- Last updated
- 9 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Combination Carboplatin and Lipsomal Doxorubicin (Doxil) In Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00006235
- Acronym / sponsor ID
- CDR0000068160
- Keywords
- recurrent ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, fallopian tube cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Primary completion
- Feb 2006 (actual)
- First posted
- 22 Jun 2004 (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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of doxorubicin HCl liposome (Doxil) when combined with carboplatin in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the rate of response in patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study of doxorubicin HCl liposome (Doxil). Patients receive Doxil IV over 1 hour and carboplatin IV on day 1. Treatment continues every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of Doxil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 0 or 1 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter until recurrence or death.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study over 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 | – |
| pegylated liposomal doxorubicin hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 9 Jul 2013.
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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.
Michael Rodriguez, MD study chair
University Hospitals Seidman Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carboplatin and pegylated liposomal doxorubicin hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by Gynecologic Oncology Group.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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 9 Jul 2013.