Clinical trial · Interventional

Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver (6655)

A Randomized Phase I/III Study Of Systematic Chemotherapy With Or Without Hepatic Chemoembolization For Liver-Dominant Metastatic Adenocarcinoma Of The Colon And Rectum

NCT00023868CI-TRIAL-00048598terminatedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): redesign

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known if chemoembolization is more effective than standard chemotherapy in treating metastatic cancer. PURPOSE: This phase I trial and randomized phase III trial is studying the effectiveness of chemoembolization in treating patients who have colorectal cancer metastatic to the liver.

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 (7)

Intervention	Type	Mapped drug	Match
cisplatin	Drug	Cisplatin	ALIAS
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
fluorouracil	Drug	Fluorouracil	ALIAS
FOLFIRI regimen	Drug	FOLFIRI Regimen	ALIAS
irinotecan hydrochloride	Drug	Irinotecan	ALIAS
leucovorin calcium	Drug	Leucovorin	ALIAS
mitomycin C	Drug	Mitomycin	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic colorectal adenocarcinoma

  * Measurable metastasis to liver at least 1.0 cm

    * Less than 75% of total liver volume
  * Known extrahepatic disease limited to lymph nodes and less than 2 cm
  * No ascites
* Ineligible for surgery

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute granulocyte count at least 2,000/mm\^3
* Platelet count at least 90,000/mm\^3
* No bleeding diathesis not correctable by standard therapy

Hepatic:

* Ineligible if all of the following criteria are concurrently present:

  * High risk of hepatic failure (more than 50% liver involvement by tumor)
  * Bilirubin greater than 2.0 mg/dL
  * SGOT greater than 100 U/L
  * Lactate dehydrogenase greater than 425 U/L
* No hepatic encephalopathy
* No portal vein occlusion without hepatopedal collateral flow demonstrated by angiography
* No portal hypertension with hepatofugal flow

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No myocardial infarction within the past 6 months
* No evidence of congestive heart failure
* No severe peripheral vascular disease that would preclude catheterization

Other:

* No severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No more than 1 prior adjuvant immunotherapy regimen for colon cancer

Chemotherapy:

* At least 6 months since prior adjuvant chemotherapy and recovered
* No more than 1 prior adjuvant chemotherapy regimen for colon cancer
* No prior hepatic arterial infusion chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 1 month since prior radiotherapy
* No prior hepatic radiotherapy

Surgery:

* At least 1 month since prior surgery
* Prior surgical resection or ablation of liver metastases allowed

Other:

* No other concurrent therapy

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 1, 2001
Primary completion: Sep 25, 2002
Completion: Sep 25, 2002
First posted: Jun 17, 2003
Last update posted: Dec 2, 2020
Lead sponsor: American College of Radiology Imaging Network NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases

Data updated 22 days agoSource updated Dec 2, 2020source: clinicaltrials

Locations

Locations by country (9)

Country	Sites	Recruiting
United States	9	0

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