Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer

NCT00002842 | Completed Phase 2 Results

• 5 other identifiers: 94080P30CA033572CHNMC-IRB-94080NCI-V96-1031CDR0000065077
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; liver metastases

Outcome Measures

Primary Outcomes (1)

• 2 Year Disease-free Survival .

  Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.

  2 years after treatment

Study Arms (1)

Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

EXPERIMENTAL

Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks

Drug: floxuridine; Drug: fluorouracil; Drug: leucovorin calcium; Procedure: adjuvant therapy; Procedure: conventional surgery

Interventions

floxuridine DRUG

Starting dose of 0.2 mg/kg/day for 14 consecutive days.

Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

fluorouracil DRUG

300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.

Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

leucovorin calcium DRUG

500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.

Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

adjuvant therapy PROCEDURE

Chemotherapy given after hepatic resection

Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

conventional surgery PROCEDURE

Hepatic resection

Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed colorectal carcinoma or radiologically confirmed colorectal carcinoma in a synchronous metastasis * Intrahepatic metastases required * No more than 15 metastases involving no more than 60% of functioning liver * No extrahepatic disease unless: * Resectable anastomotic or locally recurrent tumor * Resectable mesenteric lymph node involvement in patients undergoing initial resection of primary colorectal carcinoma * Disease extension from liver metastasis amenable to en bloc resection (e.g., diaphragm wall, kidney, abdominal wall) * No biopsy-proven chronic active hepatitis PATIENT CHARACTERISTICS: Age: * Physiologic 18 to 70 Performance status: * Karnofsky 60%-100% Hematopoietic: * AGC at least 1,500 * Platelets at least 100,000 Hepatic: * Bilirubin no greater than 2.0 mg/dL (unless reversibly obstructed by metastasis) Renal: * Creatinine no greater than 2.0 mg/dL Other: * No second malignancy within 5 years except adequately treated: * Nonmelanomatous skin cancer * In situ bladder cancer * In situ cervical cancer * No pregnant women PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior mitomycin or nitrosoureas allowed Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to the liver * At least 3 weeks since radiotherapy and recovered * Prior pelvic radiotherapy allowed * No planned concurrent radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Floxuridine; Fluorouracil; Leucovorin; 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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Uracil; Pyrimidinones; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Jeffrey Longmate, Ph.D.
• Organization: City of Hope

jlongmate@coh.org

626-256-4673

Study Officials

• Lucille A. Leong, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: September 1, 1994
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Locations

US (1)