Trial Information

Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Metastatic Breast, Colorectal, or Ovarian Cancer

OBJECTIVES:

Primary

- To determine a prognostic scale of the feasibility of chemotherapy (at least two-thirds
of the dose intensity usually administered) in patients aged 75 years or older with
breast, colorectal, or ovarian cancer.

Secondary

- To evaluate the efficacy, in terms of clinical and/or biological response, of
treatments administered.

- To evaluate the incidence of severe (grade 3-4) toxicity.

OUTLINE: This is a multicenter study. Patients receive one of the following regimens
according to cancer diagnosis and principal investigator preference. All regimens last 3
months.

- Colorectal cancer: Patients receive 1 of the following regimens:

- Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously over
46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of
disease progression or unacceptable toxicity.

- Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV
over 2 hours on day 1. Treatment repeats every 3 weeks for 4 courses in the
absence of disease progression or unacceptable toxicity.

- Breast cancer: Patients receive 1 of the following regimens:

- Patients receive paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats
every 3 weeks for 4 courses in the absence of disease progression or unacceptable
toxicity.

- Patients receive doxorubicin hydrochloride liposomal IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.

- Ovarian cancer: Patients receive carboplatin IV over 1 hour and paclitaxel IV over 2
hours on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.