Clinical trial NCT00003077: Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
Official title: Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-10-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may be an effective treatment for patients with advanced cancer who are unable to maintain their body weight.

PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating patients with advanced cancer who have significant weight loss.

Detailed description: OBJECTIVES:

* Determine whether omega-3 fatty acids will reverse weight loss in advanced cancer patients with cachexia.
* Determine the maximum tolerated dose (MTD) of omega-3 fatty acids in these patients (phase I completed 12/1999).
* Determine whether omega-3 fatty acids will result in an antitumor response.

OUTLINE: This is a randomized, stratified, dose escalation study. Patients are stratified by the extent of weight loss (2-5 percent or greater than 5 percent in the past month).

Patients receive omega-3 fatty acids orally in two equal doses with/after breakfast and lunch for 4 months or until weight loss is observed.

Dose is escalated in cohorts of two patients, although dose escalation is allowed in individual patients. The maximum tolerated dose (MTD) is defined as the highest dose level at which no greater than one-third of the patients treated, including escalated patients from a lower dose, experience grade 3 or worse toxicity (phase I completed 12/1999).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically proven advanced cancer not amenable to curative therapy (solid tumors and hematologic malignancies eligible except primary and metastatic brain tumors)
* Cachexia (weight loss at least 2 percent within a one month period)

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance Status:

* CALBG 0-2

Life Expectancy:

* At least 2 months

Hematopoietic:

* Granulocytes greater than 1,000/mm3
* Platelet count greater than 75,000/mm3
* Hemoglobin greater than 8 mg/dL

Hepatic:

* AST less than 3 times upper limit of normal (ULN)
* Alkaline phosphatase less than 3 times ULN
* Bilirubin less than 1.5 times ULN

Renal:

* BUN less than 1.5 times ULN
* Creatinine less than 1.5 times ULN

Cardiovascular:

* No congestive heart failure requiring diuretics within less than 6 months
* No uncontrolled or severe cardiovascular disease within less than 6 months
* No myocardial infarction within less than 6 months

Other:

* Not pregnant nor contemplating pregnancy during study
* Negative pregnancy test
* No uncontrolled hypercalcemia
* No metabolic disorders (hyperthyroidism)
* No poorly controlled diabetes
* No peripheral edema or ascites requiring diuretics
* No enteric fistulas, with tracheobronchial fistulas or with aspiration
* No esophageal or bowel obstruction that would preclude eating
* Free T4 within normal range
* No serious medical illness
* No psychosis
* No uncontrolled bacterial, viral, or fungal infections
* No active uncontrolled duodenal ulcers
* Above laboratory values required unless bone marrow, liver, kidney, or splenic involvement by tumor is documented

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior and concurrent chemotherapy allowed

Endocrine therapy:

* No concurrent steroids such as dronabinol or megestrol acetate (except for adrenal failure)

Radiotherapy:

* No prior or concurrent radiotherapy to abdomen or pelvis

Surgery:

* Greater than 3 weeks since major surgery
* Greater than 1 week since minor surgery

Other:

* No concurrent diuretics

Primary outcomes:
measure: survival
timeFrame: up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at The University of Iowa
state: Iowa
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Campus
state: New York
city: Winston-Salem
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
Study officials:
affiliation: Holden Comprehensive Cancer Center
name: C. Patrick Burns, MD
role: STUDY_CHAIR
References:
citation: Burns CP, Halabi S, Clamon G, Kaplan E, Hohl RJ, Atkins JN, Schwartz MA, Wagner BA, Paskett E. Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia. Cancer. 2004 Jul 15;101(2):370-8. doi: 10.1002/cncr.20362.