Clinical trial NCT00104689: Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
Official title: Phase II Trial Assessing the Impact on the Activity of Daily Living of an Oral Chemotherapy by Capecitabine Associated With an Intravenous Chemotherapy by Oxaliplatin as First Line Treatment of Metastatic Colorectal Adenocarcinoma of Patients Aged Over 70
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2005-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: OBJECTIVES:

Primary

* Determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as defined by stabilization or improvement by 1 point on Katz's Activities of Daily Living scale, in older patients with metastatic colorectal adenocarcinoma.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the percentage of patients who receive the first 3 courses of this regimen (at lower doses) and the percentage of patients who receive all 6 courses of this regimen (at both lower and higher doses).
* Determine efficacy of this regimen, as defined by RECIST criteria, in these patients.
* Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter, open-label, nonrandomized study.

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.

NOTE: \*The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the absence of unacceptable toxicity

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale
Secondary outcomes:
measure: Toxicity
measure: 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
measure: Efficacy as defined in RECIST criteria
measure: Pharmacokinetics
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Senlis
country: France
facility: C.H. Senlis
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Paoli-Calmettes
name: Frederic Viret, MD
References:
citation: 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.