Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019747

Purpose

RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the tumor. Giving thalidomide after surgery may kill any remaining tumor cells.

PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients with recurrent or metastatic colorectal cancer.

Condition	Intervention	Phase
Colorectal Cancer	Drug: thalidomide Procedure: adjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients With Recurrent Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Thalidomide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]
Time to recurrence [ Designated as safety issue: No ]
Correlation of serum/plasma levels of vascular endothelial growth factor and basic fibroblast growth factor with tumor recurrence [ Designated as safety issue: No ]
Pharmacokinetics [ Designated as safety issue: No ]
Antiangiogenic activity [ Designated as safety issue: No ]
Presence of circulating tumor cells [ Designated as safety issue: No ]

Estimated Enrollment:	94
Study Start Date:	August 1999
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo.
Compare the time to recurrence in patients treated with these regimens.
Determine whether serum/plasma levels of vascular endothelial growth factor and basic fibroblast growth factor preresection and postresection correlate with tumor recurrence and determine if these levels, as well as CEA measurements, aid in predicting time to recurrence in these patients.
Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these patients.
Determine whether patients receiving thalidomide develop measurable antiangiogenic activity.
Measure the presence of circulating tumor cells preresection and postresection and determine if this type of analysis can be used to predict recurrence in this patient population.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to site of most recent lesion resection that rendered no evidence of disease (lung vs liver with no more than 3 lesions vs liver with more than 3 lesions vs lung and liver vs all other sites[including sites that were both resected and ablated]). Patients without evidence of residual disease are randomized to one of two treatment arms.

Arm I: Patients receive oral thalidomide once daily.
Arm II: Patients receive an oral placebo once daily. Treatment continues in both arms for 2 years in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for up to 3 years.

PROJECTED ACCRUAL: A total of 94 patients (47 per treatment arm) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of recurrent or metastatic colorectal carcinoma previously resected within 12 weeks of study entry
- Surgical resection combined with radiofrequency ablation allowed

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Hemoglobin at least 8.0 g/dL
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

PTT/PT no greater than 120% of control (except in therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation])
Total bilirubin no greater than 2.0 mg/dL (direct bilirubin no greater than 1.0 mg/dL for patients with Gilbert's syndrome)
AST/ALT less than 2.5 times normal
No history of hepatic cirrhosis
No concurrent hepatic dysfunction

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

No severe congestive heart failure or active ischemic heart disease
No active clots within 1 year before diagnosis OR must be receiving concurrent treatment with anticoagulant (e.g., low molecular weight heparin or equivalent agent)

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for least 4 weeks before, during, and for at least 4 weeks after study participation
No history of severe hypothyroidism
No history of seizures
No significant history of other medical problems that would preclude surgery
No peripheral neuropathy greater than grade 1, except localized neuropathy due to a mechanical cause or trauma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior biologic therapy

Chemotherapy:

At least 4 weeks since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

See Disease Characteristics

Other:

See Cardiovascular
No concurrent sedating drugs that cannot be reduced to a minimal level
No concurrent sedating recreational drugs or alcohol
No concurrent antiseizure medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019747

Locations

United States, Indiana
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46526
United States, Maryland
Suburban Hospital Cancer Program
Bethesda, Maryland, United States, 20817
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0558
United States, Pennsylvania
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven K. Libutti, MD

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00019747 History of Changes
Other Study ID Numbers:	CDR0000067098, NCI-99-C-0102
Study First Received:	July 11, 2001
Last Updated:	February 7, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adjuvants, Immunologic
Thalidomide

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 13, 2012