Octreotide in Treating Patients With Cancer-Related Malignant Ascites (NCT00182754) | Clinical Trial Compass
CompletedPhase 3
Octreotide in Treating Patients With Cancer-Related Malignant Ascites
United States33 participantsStarted 2005-10
Plain-language summary
RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet known whether octreotide is more effective than a placebo in treating malignant ascites.
PURPOSE: This randomized phase III trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer-related malignant ascites.
Who can participate
Age range18 Years
SexALL
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 or cytologically confirmed cancer
* Diagnosis of malignant ascites, as determined by the treating oncologist
* Positive cytology not required
* Patient is symptomatic and views ascites as a problem
* No lymphoma or lymphomatous ascites
* Planning therapeutic paracentesis ≤ 3 days after study entry OR completed therapeutic paracentesis 2 days before study entry
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* At least 4 weeks
Hematopoietic
* Not at high risk of bleeding from a procedure
Hepatic
* No known cirrhosis or portal hypertension
Renal
* No known history of chronic renal failure, defined as creatinine ≥ 2 times upper limit of normal
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Prior cholecystitis allowed provided patient underwent cholecystectomy
* No uncontrolled diabetes mellitus
* No known allergy to octreotide
* No known allergy to latex
* No medical condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent bevacizumab
Chemotherapy
* No concurrent intraperitoneal chemotherapy
* No concurrent first-line chemotherapy for any cancer except pancreatic cancer
* Concurrent second-line chemotherapy or later-line chemotherapy allowed
Endocrine therapy
* No other concurrent octreotide
Radiotherapy
* Not specified
Surgery
* Not specified
Ot…