Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
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| ClinicalTrials.gov Identifier: NCT00002716 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 13, 2016
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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 may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have unresectable liver metastases from colorectal cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer Metastatic Cancer | Drug: dexamethasone Drug: floxuridine Drug: fluorouracil Drug: leucovorin calcium Procedure: laparotomy Procedure: conventional surgery | Phase 3 |
OBJECTIVES:
- Compare the efficacy, toxicity, and cost of hepatic artery infusion of floxuridine, leucovorin calcium (CF), and dexamethasone vs IV fluorouracil and IV CF after resection of primary disease in patients with hepatic metastases secondary to colorectal cancer.
- Compare the quality of life of patients treated with these regimens.
- Measure the level of thymidylate synthase present in liver metastases, and correlate these levels with objective response and survival in patients treated with these regimens.
- Assess the p53 mutations, and correlate findings with objective response and survival in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, percentage of liver involvement on CT scan or MRI (less than 30% vs 30% to under 70%), prior chemotherapy (none vs adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) completed at least 1 year before study vs adjuvant chemotherapy comprising 5-FU with or without LEV completed at least 6 months before study), and synchronous disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 135 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE (FUDR), LEUCOVORIN (LV), AND DEXAMETHASONE (DEX) VERSUS SYSTEMIC 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) AS TREATMENT FOR HEPATIC METASTASES FROM COLORECTAL CANCER |
| Study Start Date : | January 1996 |
| Actual Primary Completion Date : | March 2006 |
| Actual Study Completion Date : | August 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I - laparotomy + conventional surgery + chemotherapy
Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months. Patients are followed every 3 months. |
Drug: dexamethasone Drug: floxuridine Drug: leucovorin calcium Procedure: laparotomy Procedure: conventional surgery |
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Experimental: Arm II - conventional surgery + chemotherapy
Patients receive CF IV and fluorouracil IV on days 1-5. Patients with unresected primary disease undergo resection within 3-4 weeks before initiation of chemotherapy. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months. Patients are followed every 3 months. |
Drug: fluorouracil Drug: leucovorin calcium Procedure: conventional surgery |
- Overall survival [ Time Frame: Up to 5 years ]
- Time to progression [ Time Frame: Up to 5 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Unresectable liver metastases secondary to colorectal cancer
- Less than 70% liver involvement on CT scan or MRI
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Liver biopsy required before study unless 1 of the following conditions are met:
- Carcinoembryonic antigen greater than 30
- 5 or more liver metastases visible on CT scan or MRI
- Greater than 50% to under 70% liver involvement on CT scan or MRI
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Histologically proven primary colorectal cancer that is resected or appears resectable on CT scan and physical exam
- Documentation of previously resected primaries must be based on pathologic results of the resected tumor
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Histological documentation of synchronous disease must be based on 1 of the following:
- Biopsy of primary colorectal tumor before study
- Suspicious lesion on barium enema, colonoscopy, or sigmoidoscopy, and a liver biopsy positive for adenocarcinoma consistent with the primary colorectal tumor
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Measurable disease
- Clearly defined liver mass measuring at least 2 cm or at least 3 liver masses on CT scan or MRI
- No evidence of extrahepatic disease on CT scan and physical exam
- No portal vein occlusion or ascites
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Hepatic:
- Bilirubin no greater than 2 times normal
Other:
- No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer, carcinoma in situ of the cervix, or grade 1 bladder cancer
- Not pregnant or nursing
- Fertile patients must use effective contraception
Chemotherapy:
- At least 1 year since prior adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV)
- At least 6 months since prior adjuvant chemotherapy comprising 5-FU with or without LEV
- No other prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
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No concurrent hormonal therapy except for nondisease-related conditions, e.g.:
- Steroids for adrenal failure
- Insulin for diabetes
- Intermittent dexamethasone as an antiemetic
Radiotherapy:
- No prior radiotherapy to the liver
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002716
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center-Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| United States, Nebraska | |
| Midlands Cancer Center at Midlands Community Hospital | |
| Papillion, Nebraska, United States, 68128-4157 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Pennsylvania | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| United States, Wisconsin | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54307-3453 | |
| Australia, New South Wales | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Peru | |
| Instituto de Enfermedades Neoplasicas | |
| Lima, Peru, 34 | |
| Puerto Rico | |
| San Juan City Hospital | |
| San Juan, Puerto Rico, 00936-7344 | |
| Study Chair: | Nancy E. Kemeny, MD | Memorial Sloan Kettering Cancer Center |
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00002716 |
| Other Study ID Numbers: |
CALGB-9481 U10CA031946 ( U.S. NIH Grant/Contract ) CDR0000064553 ( Registry Identifier: NCI Physician Data Query ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | July 13, 2016 |
| Last Verified: | July 2016 |
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stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
adenocarcinoma of the colon adenocarcinoma of the rectum liver metastases |
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Colorectal Neoplasms Neoplasm Metastasis 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 Leucovorin |
Dexamethasone Fluorouracil Floxuridine Calcium Levoleucovorin Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |