Octreotide in Treating Patients With Cancer-Related Malignant Ascites
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: octreotide acetate Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients |
- Median time to paracentesis [ Designated as safety issue: No ]
- VEGF concentrations in ascitic fluid [ Designated as safety issue: No ]
- Number of paracenteses [ Designated as safety issue: No ]
- Toxicity incidence [ Designated as safety issue: Yes ]
- Average quality-of-life [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | October 2005 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive octreotide subcutaneously (SC) once on day 1.
|
Drug: octreotide acetate
Given subcutaneously
|
|
Placebo Comparator: Arm II
Patients receive placebo SC once on day 1.
|
Other: placebo
Given subcutaneously
|
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
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 122 Study Locations| Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
| Investigator: | Paul L. Schaefer, MD | Toledo Clinic, Incorporated - Main Clinic |
| Investigator: | Lynn C. Hartmann, MD | Mayo Clinic |
| Investigator: | Karin F. Giordano, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Charles L. Loprinzi, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00182754 History of Changes |
| Other Study ID Numbers: | CDR0000440922, NCCTG-N04C2 |
| Study First Received: | September 15, 2005 |
| Last Updated: | August 8, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific malignant ascites |
Additional relevant MeSH terms:
|
Ascites Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Pathologic Processes Neoplastic Processes |
Octreotide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 13, 2013