Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care	Completed	18 and over	NCI	CLB-9473 NCI-P97-0097, CALGB-9473, NCT00003077

Objectives

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

Entry 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)

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

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

Expected Enrollment

A total of 57-63 patients will be enrolled in the Phase I and II study.

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).

Patients are evaluated for cachexia response every 2 weeks, and tumor response every 4 weeks for a maximum of 4 months. If no response of cachexia or tumor after a 2 month period, patients will be discontinued from study. Patients will be followed for survival post-treatment.

Burns CP, Halabi S, Clamon G, et al.: Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia. Cancer 101 (2): 370-8, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

C. Patrick Burns, MD, Protocol chair		Ph: 319-356-2038 Email: c-burns@uiowa.edu

Registry Information
Official Title		Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
Trial Start Date		1995-10-15
Trial Completion Date		2004-11-09
Registered in ClinicalTrials.gov		NCT00003077
Date Submitted to PDQ		1997-09-10
Information Last Verified		2007-02-06
NCI Grant/Contract Number		CA31946

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