Phase 3
Completed N=33
Octreotide in Treating Patients With Cancer-Related Malignant Ascites
Metastatic cancer · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00182754 ↗
Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Apr 2017
Primary outcomePrimary: Median Time to Paracentesis — 28; 14 days — p=0.17
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to Paracentesis |
28; 14 | 0.17 |
| SECONDARY Number of Paracenteses |
0.5; 1 | — |
| SECONDARY Average Quality-of-life |
4; 3; 4; 3; 4.5; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00182754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.