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

Alternate Title

Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Basic Trial Information

Objectives

1. Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo.
2. Compare the time to recurrence in patients treated with these regimens.
3. 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.
4. Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these patients.
5. Determine whether patients receiving thalidomide develop measurable antiangiogenic activity.
6. 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.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Disease-free survival
Time to recurrence
Correlation of serum/plasma levels of vascular endothelial growth factor and basic fibroblast growth factor with tumor recurrence
Pharmacokinetics
Antiangiogenic activity
Presence of circulating tumor cells

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Libutti, MD, Protocol chair		Ph: 301-496-5049 Email: steven_Libutti@nih.gov

Registry Information
Official Title		A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients with Recurrent Colorectal Cancer
Trial Start Date		1999-08-11
Trial Completion Date		2008-12-15
Registered in ClinicalTrials.gov		NCT00019747
Date Submitted to PDQ		1999-05-24
Information Last Verified		2006-09-17

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