NCT00004187

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: Phase I/II trial to study the effectiveness of combining capecitabine and oxaliplatin in treating patients who have advanced or metastatic colorectal cancer that cannot be surgically removed.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1999

Typical duration for phase_1 colorectal-cancer

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

June 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

4.8 years

First QC Date

January 21, 2000

Last Update Submit

June 24, 2019

Conditions

Colorectal Cancer

Keywords

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

Interventions

capecitabineDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically proven unresectable, advanced or metastatic colorectal cancer Measurable disease Phase I: Any pretreatment status Phase II-N (chemotherapy naive patients): No prior chemotherapy for advanced or metastatic cancer and no prior adjuvant chemotherapy OR No prior chemotherapy for advanced or metastatic cancer and prior adjuvant chemotherapy ended more than 6 months ago Phase II-P (thymidylate synthase inhibitor pretreated patients): No thymidylate synthase inhibitor based regimen for advanced or metastatic cancer and prior adjuvant chemotherapy ended less than 6 months ago OR One thymidylate synthase inhibitor based regimen for advanced or metastatic cancer and no adjuvant thymidylate synthase inhibitor based regimen OR One thymidylate synthase inhibitor based regimen for advanced or metastatic cancer and one additional adjuvant thymidylate synthase inhibitor based regimen ended more than 6 months ago No CNS metastases PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: 0 or 1 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2 times ULN (5 times ULN if related to liver metastases) Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmia unless well controlled with medication No myocardial infarction within the past 12 months Neurologic: No peripheral neuropathy of any origin worse than grade 1 No prior or concurrent seizures or CNS disorder requiring treatment Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No dysphagia, malabsorption, or intestinal obstruction that could impact the absorption or excretion of study drug No psychiatric disability precluding informed consent or compliance No prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanomatous skin cancer No other significant medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 4 weeks since prior major gastrointestinal surgery

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, Dietrich D, Stupp R, Morant R, Honegger H, Wernli M, Herrmann R, Pestalozzi BC, Saletti P, Hanselmann S, Muller S, Brauchli P, Castiglione-Gertsch M, Goldhirsch A, Roth AD. Phase II study of capecitabine and oxaliplatin in first- and second-line treatment of advanced or metastatic colorectal cancer. J Clin Oncol. 2002 Apr 1;20(7):1759-66. doi: 10.1200/JCO.2002.07.087.

    PMID: 11919232RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

CapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Study Officials

  • Markus M. Borner, MD

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

August 5, 2004

Study Start

June 1, 1999

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

June 26, 2019

Record last verified: 2019-06

Locations

CH(1)