NCT00104689

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Jun 2003

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

9 active sites

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 30, 2003

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

3.8 years

First QC Date

March 3, 2005

Last Update Submit

February 18, 2021

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

  • Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale

Secondary Outcomes (4)

  • Toxicity

  • Percentage of patients who receive the first 3 treatment courses at a lower dose and the percentage of patients who receive all 6 treatment courses at both lower and higher doses

  • Efficacy as defined in RECIST criteria

  • Pharmacokinetics

Study Arms (1)

Capecitabine + Oxaliplatin

EXPERIMENTAL

Patients receive oral capecitabine once daily on days 1-14 and oxaliplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity

Drug: capecitabineDrug: oxaliplatin

Interventions

capecitabineDRUG
Capecitabine + Oxaliplatin
oxaliplatinDRUG
Capecitabine + Oxaliplatin

Eligibility Criteria

Age70 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of colorectal adenocarcinoma * Metastatic disease * Requires first-line therapy for metastatic disease PATIENT CHARACTERISTICS: Age * Over 70 Performance status * Katz's Activities of Daily Living scale \< 6 (≤ 6 for patients ≥ 80 years of age) Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * AST and ALT \< 2 times normal (5 times normal if due to hepatic metastases) * Bilirubin \< 2 times normal (5 times normal if due to hepatic metastases) Renal * Creatinine clearance \> 30 mL/min Other * No clinical neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 6 months since prior adjuvant chemotherapy * No prior chemotherapy for metastatic disease Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (9)

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Polyclinique Francheville

Périgueux, 24004, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (1)

  • Viret F, Bugat R, Ducreux M, et al.: XELOX regimen in elderly patients with metastatic colorectal cancer (MCRC), a FNCLCC French Collaborative Group GERICO 02 phase II study. [Abstract] J Clin Oncol 25 (Suppl 18): A-19513, 708s, 2007.

    RESULT

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

  • Frederic Viret, MD

    Institut Paoli-Calmettes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

June 30, 2003

Primary Completion

March 31, 2007

Study Completion

January 1, 2008

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

FR(9)