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Alkylating Agent
Squalamine + Carboplatin for Ovarian Cancer
Phase 2
Waitlist Available
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
Cardiovascular: No significant cardiac disease No uncontrolled high blood pressure No unstable angina No congestive heart failure No myocardial infarction within the past year No serious cardiac arrhythmia requiring medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well giving squalamine lactate together with carboplatin works in treating patients with ovarian cancer.
Who is the study for?
This trial is for adults over 18 with stage III or IV ovarian cancer that has come back or didn't respond to initial treatments including paclitaxel and carboplatin. Participants must have measurable disease, certain levels of a tumor marker (CA125), and be in good physical condition without serious heart issues, uncontrolled infections, diabetes, other cancers, or pregnancy.Check my eligibility
What is being tested?
The study tests the combination of squalamine lactate and carboplatin to see if it's effective against recurrent or resistant ovarian cancer. Squalamine lactate may block blood flow to tumors while carboplatin stops cancer cells from dividing.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, lowered blood cell counts leading to increased infection risk; neuropathy; allergic reactions; and possibly cardiovascular complications due to squalamine lactate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is normal, with creatinine levels at or below 1.5 mg/dL or clearance above 60 mL/min.
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My heart is healthy and I don't have serious heart conditions.
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I am fully active or can carry out light work.
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My liver function tests are within acceptable limits.
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I am 18 years old or older.
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My ovarian cancer is confirmed to be in stage III or IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,075 Total Patients Enrolled
5 Trials studying Ovarian Cancer
212 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
285 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Linnea Chap, MDStudy ChairJonsson Comprehensive Cancer Center
3 Previous Clinical Trials
298 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been treated with squalamine lactate.I am not using any growth factors except for epoetin alfa.I have had chemotherapy for another cancer within the last 5 years.I haven't started any hormonal therapy in the last 6 months.I've had radiotherapy where my cancer can be measured and it got worse after.My cancer did not respond or came back within a year after treatment with paclitaxel and carboplatin.I have not taken any biological response modifiers.My brain metastases are stable after treatment.My kidney function is normal, with creatinine levels at or below 1.5 mg/dL or clearance above 60 mL/min.My heart is healthy and I don't have serious heart conditions.I have had more than 3 chemotherapy treatments for ovarian cancer.I am fully active or can carry out light work.My liver function tests are within acceptable limits.I am 18 years old or older.I am currently receiving treatment for cancer.I have never been treated with drugs that stop the formation of new blood vessels.I have had radiotherapy for another cancer within the last 5 years.My ovarian cancer is confirmed to be in stage III or IV.My cancer can be measured or has high CA125 levels.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to sign up for this clinical investigation?
"Per the information on clinicaltrials.gov, this particular trial is not actively enrolling patients at present. The research project was first listed on May 1st 2001 and underwent its final update in December 17th 2013. Nevertheless, there are 677 additional studies that are currently seeking participants to join their medical investigations."
Answered by AI
Have regulatory agencies sanctioned this procedure?
"The safety of this treatment is tentatively rated at 2, as Phase 2 clinical trials have been conducted without confirmation on efficacy."
Answered by AI
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