NCT00030797

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Feb 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 25, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

February 14, 2002

Last Update Submit

May 14, 2012

Conditions

Colorectal Cancer

Keywords

stage III colon cancerstage IV colon cancerstage III rectal cancerstage IV rectal cancer

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;

Drug: Irinotecan 70 mg/m2

Arm B

ACTIVE COMPARATOR

Irinotecan i.v. 240 mg/m2 day 1 and day 22; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;

Drug: Irinotecan 240 mg/m2

Interventions

Irinotecan 70 mg/m2DRUG

Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29

Arm A
Irinotecan 240 mg/m2DRUG

Irinotecan i.v. 240 mg/m2 day 1 and day 22

Arm B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Related 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 and two different schedules of irinotecan in first-line treatment of metastatic colorectal cancer: efficacy, quality-of-life and toxicity. Ann Oncol. 2005 Feb;16(2):282-8. doi: 10.1093/annonc/mdi047.

    PMID: 15668285RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Markus M. Borner, MD

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

June 25, 2003

Study Start

February 1, 2001

Primary Completion

May 1, 2002

Study Completion

December 1, 2003

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CH(1)