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A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients With Recurrent Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients With Recurrent Colorectal Cancer


- Compare the disease-free survival probability in patients with previously resected
recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs

- 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 carcinoembryonic antigen (CEA) measurements,
aid in predicting time to recurrence in these patients.

- Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these

- Determine whether patients receiving thalidomide develop measurable antiangiogenic

- 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

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.

Inclusion Criteria


- Diagnosis of recurrent or metastatic colorectal carcinoma previously resected within
12 weeks of study entry

- Surgical resection combined with radiofrequency ablation allowed



- 18 and over

Performance status:

- Not specified

Life expectancy:

- Not specified


- Hemoglobin at least 8.0 g/dL

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3


- Partial thromboplastin time (PTT)/prothrombin time (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)

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 2.5 times

- No history of hepatic cirrhosis

- No concurrent hepatic dysfunction


- Creatinine no greater than 2.0 mg/dL


- 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)


- 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


Biologic therapy:

- At least 4 weeks since prior biologic therapy


- At least 4 weeks since prior chemotherapy

Endocrine therapy:

- Not specified


- At least 4 weeks since prior radiotherapy


- See Disease Characteristics


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Description:

Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Outcome Time Frame:

62 months

Safety Issue:


Principal Investigator

Steven K. Libutti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

December 2008

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms



Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
Center for Cancer Care at Goshen Health System Goshen, Indiana  46526
Suburban Hospital Cancer Program Bethesda, Maryland  20817
UPMC Cancer Center at UPMC Presbyterian Pittsburgh, Pennsylvania  15213