Phase 2
N=49
Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
Colorectal Cancer · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00002842 ↗Enrolled (actual)
49
Serious AEs
36.4%
Results posted
Apr 2017
Primary outcome: Primary: 2 Year Disease-free Survival . — 9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- floxuridine (Drug); fluorouracil (Drug); leucovorin calcium (Drug); adjuvant therapy (Procedure); conventional surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- City of Hope Medical Center
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2 Year Disease-free Survival . |
9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00002842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.