Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030797
• Other study ID #: SAKK 41/00
• Secondary ID: EU-20141
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2002
• Last updated: May 14, 2012
• Start date: February 2001
• Est. completion date: December 2003

Study information

• Verified date: May 2012
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• 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: Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic colorectal cancer.

Description:

OBJECTIVES:

• Compare the efficacy of different schedules of irinotecan in combination with capecitabine as first-line therapy, in terms of objective response rate, in patients with advanced or metastatic colorectal cancer.

• Compare the time to treatment failure, time to progression, and overall survival of patients treated with these regimens.

• Compare the safety profile, in terms of toxicity, of these regimens in these patients.

• Determine the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1); disease symptoms, including pain, weight loss, loss of appetite, malaise, and fever of unknown origin (yes vs no); weight loss during the past 6 months (more than 5% vs 5% or less); and disease-free interval (more than 6 months vs 6 months or less). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive irinotecan IV over 1 hour on days 1, 8, 15, 22, and 29 and oral capecitabine twice daily on days 1-14 and 22-35.

• Arm II: Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral capecitabine as in arm I.

Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of each course, and at the first visit after treatment failure.

Patients are followed every 12 weeks for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per treatment arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2003
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced or metastatic colorectal cancer

• Unresectable disease

• At least 1 bidimensionally measurable lesion

• At least 2 cm in perpendicular diameters

• No evidence of CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• 0-1

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,500/mm^3

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

Hepatic:

• Bilirubin normal

• SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.25 times ULN

Cardiovascular:

• No clinically significant cardiac disease

• No congestive heart failure

• No New York Heart Association class III or IV heart disease

• No symptomatic coronary artery disease

• No uncontrolled cardiac arrhythmia

• No myocardial infarction within the past year

Gastrointestinal:

• No evidence of dysphagia

• No malabsorption or intestinal obstruction that would affect absorption or excretion of study drugs

• No chronic diarrhea

Other:

• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer

• No psychiatric disability that would preclude study compliance

• No other significant medical condition

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for advanced or metastatic disease

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• At least 4 weeks since prior major surgery to the gastrointestinal tract

Other:

• No concurrent therapy for history of seizures or CNS disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Irinotecan 70 mg/m2
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29
• Irinotecan 240 mg/m2
Irinotecan i.v. 240 mg/m2 day 1 and day 22

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Borner MM, Bernhard J, Dietrich D, Popescu R, Wernli M, Saletti P, Rauch D, Herrmann R, Koeberle D, Honegger H, Brauchli P, Lanz D, Roth AD; Swiss Group for Clinical Cancer Research (SAKK), Berne, Switzerland. A randomized phase II trial of capecitabine a — View Citation