Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Phase II Study of Oral Xeloda in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022698
• Other study ID #: CDR0000068843
• Secondary ID: ROCHE-ML16323
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: July 23, 2008
• Start date: March 2001

Study information

• Verified date: February 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.

Description:

OBJECTIVES:

• Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan.

• Determine the time to treatment failure, time to overall response, duration of overall complete response, and time to progression in patients treated with this regimen.

• Determine the 1-year survival and overall survival of patients treated with this regimen.

• Determine the toxicity and safety profile of this regimen in these patients.

• Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma

• At least 1 measurable lesion

• At least 10 mm by spiral CT scan

• At least 20 mm by conventional techniques

• Bone metastases, ascites, or pleural effusions are not considered measurable disease

• No evidence of CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)

• ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)

• Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present)

• No known Gilbert's disease

Renal:

• Creatinine no greater than 1.5 times ULN

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No clinically significant cardiac disease

• No congestive heart failure

• No symptomatic coronary artery disease

• No cardiac arrhythmias uncontrolled with medication

• No myocardial infarction within the past 12 months

Gastrointestinal:

• Able to swallow tablets

• No lack of physical integrity of the upper gastrointestinal tract

• No malabsorption syndrome

Other:

• No prior unanticipated severe reaction to fluoropyrimidine therapy

• No hypersensitivity to fluorouracil

• No history of uncontrolled seizures or CNS disorders

• No psychological illness or condition that would preclude study entry

• No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

• No serious infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy

• No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer

• No concurrent prophylactic hematopoietic growth factors

Chemotherapy:

• At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy

• No prior chemotherapy for metastatic colorectal cancer

• No prior irinotecan or capecitabine

• No other concurrent cytotoxic agents

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy

• No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed)

• No concurrent radiotherapy

Surgery:

• At least 4 weeks since prior major surgery and recovered

• No prior organ allograft

Other:

• At least 4 weeks since prior participation in an investigational drug study

• No other concurrent investigational drugs

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• capecitabine

• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Lincoln Medical and Mental Health Center	Bronx	New York
United States	HemOnCare, P.C.	Brooklyn	New York
United States	Charleston Hematology-Oncology, P.A.	Charleston	South Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	University of Florida Health Science Center - Jacksonville	Jacksonville	Florida
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	St. Louis University Hospital Cancer Center	Saint Louis	Missouri
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	Rockwood Clinic P.S.	Spokane	Washington
United States	George Washington University Medical Center	Washington	District of Columbia
United States	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (2)

Carlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, Rogatko A, Wang H, Blanchard RL. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res. 2005 Feb 1;11(3 — View Citation

Meropol NJ, Gold PJ, Diasio RB, Andria M, Dhami M, Godfrey T, Kovatich AJ, Lund KA, Mitchell E, Schwarting R. Thymidine phosphorylase expression is associated with response to capecitabine plus irinotecan in patients with metastatic colorectal cancer. J C — View Citation