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

Alternate Title

FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	NCI	SWOG-S0336 S0336, NCT00077337

Objectives

1. Determine the confirmed response (complete and partial) in patients with previously treated unresectable locally advanced or metastatic colorectal cancer treated with FR901228 (depsipeptide).
2. Determine the time to treatment failure and overall survival of patients treated with this drug.
3. Determine the qualitative and quantitative toxic effects of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed colorectal cancer meeting 1 of the following criteria:
  • Locally advanced unresectable disease
  • Distant metastatic disease
• Measurable disease
• Previously treated with at least 1, but no more than 2, prior chemotherapy regimens for unresectable locally advanced or metastatic disease
  • May have included irinotecan or oxaliplatin
  • No more than 1 prior chemotherapy regimen (not oxaliplatin-based) for advanced or metastatic disease if previously treated with oxaliplatin-based adjuvant chemotherapy
  • No more than 1 prior chemotherapy regimen (not irinotecan-based) for advanced or metastatic disease if previously treated with irinotecan-based adjuvant chemotherapy
• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent anticancer immunotherapy

Chemotherapy

• See Disease Characteristics
• At least 28 days since prior chemotherapy and recovered
• No prior FR901228 (depsipeptide)
• No other concurrent anticancer chemotherapy

Endocrine therapy

• No concurrent anticancer hormonal therapy

Radiotherapy

• At least 28 days since prior radiotherapy and recovered
• No concurrent anticancer radiotherapy

Surgery

• At least 28 days since prior surgery and recovered

Other

• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent agent that causes QTc prolongation
• No concurrent hydrochlorothiazide
• No other concurrent investigational agents
• No other concurrent drugs that have histone deacetylase inhibitor activity (e.g., valproic acid)
• No other concurrent anticancer therapy

Patient Characteristics:

Age

• Over 18

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ upper limit of normal (ULN)
• SGOT and SGPT ≤ 2.5 times ULN

Renal

• Creatinine ≤ ULN

Cardiovascular

• No New York Heart Association class III or IV congestive heart failure
• No myocardial infarction within the past year
• No uncontrolled dysrhythmias
• No poorly controlled angina
• No prior serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
• No left ventricular hypertrophy
• QTc < 500 msec
• No other significant cardiac disease

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to FR901228

Expected Enrollment

A total of 20-40 patients will be accrued for this study within 4-10 months.

Outline

This is a multicenter study.

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression and then every 3 months until 1 year after study entry and then every 6 months until 3 years after study entry.

Whitehead RP, Rankin C, Hoff PM, et al.: Phase II trial of romidepsin (NSC-630176) in previously treated colorectal cancer patients with advanced disease: a Southwest Oncology Group study (S0336). Invest New Drugs 27 (5): 469-75, 2009.[PUBMED Abstract]

Whitehead RP, McCoy S, Wollner IS, et al.: Phase II trial of depsipeptide (NSC-630176) in colorectal cancer patients who have received either one or two prior chemotherapy regimens for metastatic or locally advanced, unresectable disease: a Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-255, 2006.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Robert Whitehead, MD, Study coordinator(Contact information may not be current)		Ph: 409-772-2981

Registry Information
Official Title		Phase II Trial of Depsipeptide (NSC-630176) in Colorectal Cancer Patients Who Have Received Either One or Two Prior Chemotherapy Regimens for Metastatic or Locally Advanced, Unresectable Disease
Trial Start Date		2004-04-19
Registered in ClinicalTrials.gov		NCT00077337 1
Date Submitted to PDQ		2003-12-19
Information Last Verified		2005-11-01
NCI Grant/Contract Number		U10-CA32102

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00077337