Clinical trial · Interventional

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

Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma

NCT00002842CI-TRIAL-00026900completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Metastatic Cancer	Malignant Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
adjuvant therapy	Procedure	—	UNRESOLVED
conventional surgery	Procedure	—	UNRESOLVED
floxuridine	Drug	—	UNRESOLVED
fluorouracil	Drug	Fluorouracil	ALIAS
leucovorin calcium	Drug	Leucovorin	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
description
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
interventionNames
1. Drug: floxuridine
2. Drug: fluorouracil
3. Drug: leucovorin calcium
4. Procedure: adjuvant therapy
5. Procedure: conventional surgery

Primary outcomes (1)

measure
2 Year Disease-free Survival .
timeFrame
2 years after treatment
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Sep 1, 1994
Primary completion: May 1, 2014
Completion: May 1, 2014
First posted: Jan 27, 2003
Last update posted: Apr 11, 2017
Results first posted: Apr 11, 2017
Enrollment: 49 (actual)
Lead sponsor: City of Hope Medical Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases

Data updated 22 days agoSource updated Apr 11, 2017source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.