|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 Lead Organizations/Sponsors
North Central Cancer Treatment GroupNational Cancer Institute
|Aminah Jatoi||Study Chair|
|Paul L. Schaefer|
|Lynn Carol Hartmann|
|Karin F. Giordano|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00182754
Information obtained from ClinicalTrials.gov on February 20, 2013
Back to Top