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

NCT00019747 | Terminated Phase 2 Results DMC

• 3 other identifiers: 99010299-C-0102CDR0000067098
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  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

  62 months

Study Arms (2)

Arm 1 - Thalidomide once daily

EXPERIMENTAL

Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).

Drug: thalidomide; Procedure: adjuvant therapy

Arm 2 - Placebo once daily

PLACEBO COMPARATOR

Patients receive oral placebo once daily.

Procedure: adjuvant therapy; Other: Placebo

Interventions

thalidomide DRUG

oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).

Also known as: Thalomid

Arm 1 - Thalidomide once daily

adjuvant therapy PROCEDURE

Initial dose: 100 mg by mouth (po) every bedtime ( Q hs) for four weeks, then progress to 200 mg po Q hs for four weeks, then progress to maintenance dose: 300 mg po Q hs.

Arm 1 - Thalidomide once daily; Arm 2 - Placebo once daily

Placebo OTHER

oral placebo once daily

Arm 2 - Placebo once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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: * 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Center for Cancer Care at Goshen Health System

Goshen, Indiana, 46526, United States

Location

Suburban Hospital Cancer Program

Bethesda, Maryland, 20817, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0558, United States

Location

UPMC Cancer Center at UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Thalidomide; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Steven A. Rosenberg, M.D.
• Organization: National Cancer Institute, National Institutes of Health

sar@mail.nih.gov

301-496-4164

Study Officials

• Steven K. Libutti, MD

  NCI - Surgery Branch

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Steven Rosenberg

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 1999
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 28, 2015
• Results First Posted: October 25, 2012

Record last verified: 2015-09

Locations

US (6)