Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tu… (NCT00003385) | Clinical Trial Compass
CompletedPhase 1
Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
United States, Norway48 participantsStarted 1999-03
Plain-language 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 combination chemotherapy consisting of liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated ovarian, peritoneal, or fallopian tube cancer.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma
* The following histologic epithelial cell types are eligible:
* Serous adenocarcinoma
* Endometrioid adenocarcinoma
* Mucinous adenocarcinoma
* Undifferentiated carcinoma
* Clear cell adenocarcinoma
* Mixed epithelial carcinoma
* Transitional cell
* Malignant Brenner tumor
* Adenocarcinoma not otherwise specified
* No more than 12 weeks since diagnosis
* No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT/SGPT no greater than 3 times normal
* Alkaline phosphatase no greater than 3 times normal
* Gamma-glutamyl-transferase no greater than 3 times normal
* No acute hepatitis
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance greater than 50 mL/min
Cardiovascular:
* LVEF normal by MUGA
* No unstable angina
* No myocardial infarction within the past 6 months
* Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if disease has been stable for the past 6 months
Other:
* No septicemia or severe infectio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.