Octreotide in Treating Patients With Cancer-Related Malignant Ascites
Basic Trial Information
|Phase III||Treatment||Closed||18 and over||NCI, Other||CDR0000440922|
NCCTG-N04C2, N04C2, NCT00182754
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.
Further Study Information
- Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites.
- Compare the number of paracenteses in patients treated with these drugs.
- Determine the toxicity of octreotide in these patients.
- Compare the quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to anticipated ongoing chemotherapy (yes vs no), frequency of prior paracentesis (never vs other), and prior chemotherapy (never vs only first-line chemotherapy vs second-line chemotherapy vs other). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive octreotide subcutaneously (SC) once on day 1.
- Arm II: Patients receive placebo SC once on day 1. In both arms, treatment with intramuscular octreotide or placebo repeats monthly for up to 2 years in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, 2 weeks, and then monthly for up to 2 years during study treatment.
After completion of study treatment, patients are followed every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 68 patients (34 per treatment arm) will be accrued for this study.
- 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
- 18 and over
- Not specified
- At least 4 weeks
- Not at high risk of bleeding from a procedure
- No known cirrhosis or portal hypertension
- No known history of chronic renal failure, defined as creatinine ≥ 2 times upper limit of normal
- 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:
- No concurrent bevacizumab
- No concurrent intraperitoneal chemotherapy
- No concurrent first-line chemotherapy for any cancer except pancreatic cancer
- Concurrent second-line chemotherapy or later-line chemotherapy allowed
- No other concurrent octreotide
- Not specified
- Not specified
- No concurrent therapeutic warfarin
- Concurrent prophylactic warfarin at a dose of 1 mg/day allowed
- No other concurrent treatment for ascites except paracentesis or ongoing diuretics
Trial Contact Information
Trial Lead Organizations/Sponsors
North Central Cancer Treatment Group
- National Cancer Institute
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00182754
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.