PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer (NCT00055705) | Clinical Trial Compass
CompletedPhase 1
PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
United StatesStarted 2003-01
Plain-language summary
RATIONALE: PV701 may be able to kill tumor cells while leaving normal cells undamaged.
PURPOSE: Phase I trial to study the effectiveness of PV701 in treating patients who have advanced or recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or other cancer found primarily within the peritoneal cavity.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Histological confirmation of 1 of the following:
* Ovarian epithelial carcinoma
* Fallopian tube cancer
* Primary peritoneal cancer
* Advanced colorectal carcinoma
* Other malignancy confined to the peritoneal cavity or peritoneal surfaces
* No lesion greater than 2 cm in greatest diameter based on surgical re-assessment
* Low burden of tumor in the abdominal or pelvic cavities and no clinically significant ascites
* Received potentially effective therapy when available (e.g., platinum/taxane for ovarian cancer, fluoropyrimidine-based therapy for colorectal cancer)
* No concurrent hematological malignancy (e.g., chronic lymphocytic leukemia or non-Hodgkin's lymphoma)
* No bilateral adrenal metastases
* No adrenal metastases in the remaining adrenal gland after adrenalectomy (including radical nephrectomy)
* No lung tumors 5 cm or more
* No pleural effusions (at least 25% of hemithorax) by radiography
* No CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* More than 3 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 9 g/dL
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 1.5 times ULN
* No uncontrolled hepatic dysfunction
* No ac…
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.