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 range18 Years
SexALL
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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…