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Alkylating agents
Hyperthermia + Chemotherapy for Advanced Gynecological & Breast Cancers
Phase 2
Waitlist Available
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pulmonary criteria: FEV_1 greater than 70% of predicted, Arterial pressure of oxygen greater than 60 mmHg on room air with appropriate pressure of carbon dioxide and pH values, No history of cardiopulmonary or respiratory disease
Hepatic criteria: Bilirubin less than 2.0 mg/dL, SGPT less than 2 times normal, PT less than 14 sec, PTT less than 35 sec
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing how effective chemotherapy is when combined with hyperthermia (raising body temperature to kill tumor cells) in treating metastatic breast, ovarian, endometrial, or cervical cancer.
Who is the study for?
This trial is for adults with metastatic breast, ovarian, endometrial, or cervical cancer. Participants must have a life expectancy of at least 12 weeks, measurable disease, normal organ function (liver, kidney), no diabetes or serious illnesses, and no history of severe heart or lung conditions. Prior chemotherapy is acceptable.Check my eligibility
What is being tested?
The study tests the effectiveness of combining hyperthermia therapy (heating body tissue to damage and kill cancer cells) with two chemotherapy drugs: fluorouracil and liposomal doxorubicin. It aims to see if this combination is more effective in treating certain types of metastatic cancers.See study design
What are the potential side effects?
Potential side effects include typical reactions to chemotherapy such as nausea, fatigue, hair loss; plus specific risks from hyperthermia like burns or overheating-related complications. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function is good, and I have no history of lung or heart disease.
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My liver functions are within normal limits.
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I don't have seizures or brain disorders, and my brain scan is clear.
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I can take care of myself and am up more than 50% of my waking hours.
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I have a confirmed diagnosis of advanced cancer in the breast, ovary, uterus, or cervix.
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My kidney function tests are within the required range.
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My heart is healthy with no history of heart attacks or unstable blood pressure.
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I do not have diabetes or any serious illness.
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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicity
Tumor response
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,943 Total Patients Enrolled
1 Trials studying Ovarian Cancer
660 Patients Enrolled for Ovarian Cancer
Joan M.C. Bull, MDStudy ChairThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
78 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function is good, and I have no history of lung or heart disease.My liver functions are within normal limits.I don't have seizures or brain disorders, and my brain scan is clear.Less than 80% of my liver is affected by disease.I can take care of myself and am up more than 50% of my waking hours.I have never had a lymphoproliferative disorder.I have a confirmed diagnosis of advanced cancer in the breast, ovary, uterus, or cervix.My cancer has not spread to my brain.I haven't had any cancer, except for skin cancer, in the last 5 years.Less than 30% of my lungs are affected by the disease.I am currently taking heart or blood thinning medications.My kidney function tests are within the required range.I have symptoms of heart disease.My kidney function is reduced with a creatinine clearance below 45 mL/min.I have seizures or other brain disorders.I have a history of blood clots.I have never had cancer before.I am younger than 18 years old.I have had a heart attack before.My blood pressure frequently changes.I have a history of heart or lung disease.I have diabetes.My heart is healthy with no history of heart attacks or unstable blood pressure.I do not have diabetes or any serious illness.
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 researchers currently looking for new participants for this trial?
"Unfortunately, this particular clinical trial is not presently looking for candidates according to the most recent information found on clinicaltrials.gov. This study was initially posted on 11/1/1997 and was most recently updated on 4/29/2009; however, there are many other studies that are still enrolling patients."
Answered by AI
Will this medication produce any harmful side effects?
"This is a Phase 2 trial, meaning that while there are some data supporting safety, there are no data yet supporting efficacy. As such, our team at Power has given it a score of 2."
Answered by AI
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