Status:
COMPLETED
Octreotide in Treating Patients With Cancer-Related Malignant Ascites
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 randomi...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites. Secondary * Comp...
Eligibility Criteria
Inclusion
- 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
- Other
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00182754
Start Date
October 1 2005
End Date
March 1 2013
Last Update
April 11 2017
Active Locations (122)
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1
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
2
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
3
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
4
St. Anthony Central Hospital
Denver, Colorado, United States, 80204