Phase 3 N=33 Randomized Double-blind Treatment

Octreotide in Treating Patients With Cancer-Related Malignant Ascites

Metastatic Cancer · Unspecified Adult Solid Tumor, Protocol Specific

Bottom Line

View on ClinicalTrials.gov: NCT00182754 ↗

Enrolled (actual)

Serious AEs

3.0%

Results posted

Apr 2017

Primary outcome: Primary: Median Time to Paracentesis — 28; 14 days — p=0.17

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: octreotide acetate (Drug); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Sep 2009

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	—

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.

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

View full record on ClinicalTrials.gov →

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.