A Phase 3 interventional study of capecitabine and floxuridine in Colorectal Cancer and Metastatic Cancer, sponsored by NSABP Foundation Inc. Terminated at 31 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-15.
Sponsored by NSABP Foundation Inc · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.
PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized study. Patients are stratified according to intended surgical technique (surgical resection alone vs cryoablation or radiofrequency ablation [RFA] alone vs combination of resection and ablation) and prior adjuvant chemotherapy regimen (chemotherapy with vs without oxaliplatin vs no chemotherapy). Patients are randomized to 1 of 2 treatment arms.
All patients undergo surgical resection and/or hepatic cryoablation or RFA to remove a maximum of 6 colorectal hepatic metastases. Patients randomized to arm II also undergo intra-arterial catheter and if applicable, pump placement.
Quality of life is assessed at baseline, 4-6 weeks after surgery or ablation, approximately 18 weeks after beginning of chemotherapy, and 4-6 weeks after beginning the last cycle of chemotherapy.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 22 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →NSABP Foundation Inc is the lead sponsor of 64 studies on the registry; 1 is open to participants now.
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DISEASE CHARACTERISTICS:
Histologically* or cytologically confirmed colorectal adenocarcinoma
Synchronous or metachronous metastatic disease confined to the liver
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior resection/ablation, hepatic arterial infusion therapy, or any systemic chemotherapy for metastatic disease
No concurrent bevacizumab in patients who have had pump/catheter placement receiving hepatic arterial infusion of floxuridine
No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) as primary prophylaxis for neutropenia
Within 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity.
Drug: capecitabine · Drug: oxaliplatin
Within 4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 cycles in the absence of unacceptable toxicity. Beginning with cycle 5, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 cycles.
Drug: capecitabine · Drug: floxuridine · Drug: oxaliplatin
Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1 Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles: Arm 2
Also known as: Xeloda
Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles
Also known as: FUDR
Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1 Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles: Arm 2
Also known as: Eloxatin
Progression-free Interval (PFI)
Time to first recurrence of colon cancer at any site
Time frame: Time from randomization through year 5
Liver PFI as Measured by Time to Hepatic Progression.
Time frame: Time from randomization through year 5
Survival as Measured by Time to Death From Any Cause.
Time frame: Time from randomization through year 5
Scales Specific to Social/Family, Emotional, and Functional Well-being, Perceived Convenience of Care, and Self-reported Symptoms
Time frame: Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Trial Outcome Index at Baseline, at 4-6 Weeks Following Surgery (Before Initiation of Chemotherapy), and Periodically During Study
Time frame: Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy
| Milestone | Arm 1: Capecitabine + Oxaliplatin | Arm 2: Floxuridine + Oxaliplatin + Capecitabine |
|---|---|---|
| Started | 10 | 12 |
| Completed | 0 | 0 |
| Not completed | 10 | 12 |
| Withdrew: Study terminated due to low accrual | 10 | 12 |
Time to first recurrence of colon cancer at any site
No measurements were reported for this outcome.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Capecitabine + Oxaliplatin | — | 0/8 (0%) | 6/8 (75%) |
| Floxuridine + Oxaliplatin + Capecitabine | — | 0/6 (0%) | 3/6 (50%) |
| Event | Capecitabine + Oxaliplatin | Floxuridine + Oxaliplatin + Capecitabine |
|---|---|---|
| NauseaGastrointestinal disorders | 3/8 | 1/6 |
| Peripheral sensory neuropathyNervous system disorders | 3/8 | 1/6 |
| Abdominal painGastrointestinal disorders | 0/8 | 2/6 |
| FatigueGeneral disorders | 0/8 | 2/6 |
| VomitingGastrointestinal disorders | 2/8 | 2/6 |
| HyperglycemiaMetabolism and nutrition disorders | 2/8 | 0/6 |
| Neutrophil count decreasedInvestigations | 2/8 | 1/6 |
| Alanine aminotransferase increased (ALT/SGPT)Investigations | 0/8 | 1/6 |
| AnorexiaMetabolism and nutrition disorders | 1/8 | 1/6 |
| Aspartate aminotransferase increased (AST/SGOT)Investigations | 0/8 | 1/6 |
| Age Continuous(years) | Capecitabine + Oxaliplatin | Floxuridine + Oxaliplatin + Capecitabine | Total |
|---|---|---|---|
| Mean | 60 ± 10.4 | 59 ± 9.4 | 59 ± 9.7 |
| Sex/Gender, Customized(participants) | Capecitabine + Oxaliplatin | Floxuridine + Oxaliplatin + Capecitabine | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 7 | 7 | 14 |
| Unknown | 0 | 1 | 1 |
This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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NSABP Foundation Inc