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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mike Andria

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Federal Government

Study ID:

CDR0000068843

NCT ID:

NCT00022698

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms

Name

Location

George Washington University Medical CenterWashington, District of Columbia  20037
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Rockwood Clinic P.S.Spokane, Washington  99202
University of Florida Health Science Center - JacksonvilleJacksonville, Florida  32209
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
HemOnCare, P.C.Brooklyn, New York  11235
Lincoln Medical and Mental Health CenterBronx, New York  10451
Charleston Hematology-Oncology, P.A.Charleston, South Carolina  29403