Combination Chemotherapy in Treating Older Patients With Metastatic Breast, Colorectal, or Ovarian Cancer That Cannot Be Removed by Surgery - Full Text View

Sponsored by:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00664911

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with metastatic breast, colorectal, or ovarian cancer that cannot be removed by surgery.

Condition	Intervention
Breast Cancer Colorectal Cancer Ovarian Cancer	Drug: capecitabine Drug: carboplatin Drug: fluorouracil Drug: oxaliplatin Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Carboplatin Paclitaxel Capecitabine Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Metastatic Breast, Colorectal, or Ovarian Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Number of patients hospitalized [ Designated as safety issue: No ]
Number of patients receiving therapeutic dose-intensive therapy (doses must be at least equivalent to two-thirds the dose that is usually administered according to AMM recommendations) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor response according to RECIST criteria and/or a decrease of at least 50% of markers measured within 4 months of starting study therapy [ Designated as safety issue: No ]
Grade 3-4 toxicities according to NCI-CTCAE version 3 [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	March 2008
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	75 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the breast, colon, rectum, or ovaries
- M1 disease for patients with breast or colorectal cancer
- Stage III (with residual disease) or IV ovarian cancer
Previously untreated metastatic disease
Not surgically resectable
Measurable disease by RECIST criteria OR evaluable disease by one of the following tumor biomarkers:
- Colorectal cancer: ACE
- Breast cancer: CA 15-3
- Ovarian cancer: CA 125

PATIENT CHARACTERISTICS:

Life expectancy at least 3 months
ANC > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin > 9 g/dL
AST and ALT < 5 times upper limit of normal (ULN)
Total bilirubin < 1.5 times ULN
Creatinine < 1.5 times ULN and creatinine clearance > 30 mL/min
LDH level known
No other uncontrolled disease
Patient must be in control of him/herself
No known contraindication to study drugs
No cerebral cardiovascular accident or myocardial infarction within the past 6 months
No other cancer within the past 5 years except resected carcinoma of the skin, completely resected localized cutaneous melanoma, or resected cervical cancer
No contraindication due to psychological, social, or geographical reasons that would preclude study treatment and follow-up

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior adjuvant chemotherapy except for the following:
- Fluorouracil alone completed more than 6 months ago for colorectal cancer
- Oxaliplatin completed more than 2 years ago for colorectal cancer
- Total dose received of doxorubicin ≤ 300 mg/m^2 and epirubicin ≤ 600 mg/m^2 for breast cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664911

Locations

France
C.H. Senlis	Recruiting
Senlis, France, 60309
Contact: Elisabeth Carola, MD 33-3-4421-7026
Centre de Gerontologie Les Abondances	Recruiting
Boulogne-Billancourt, France, 92100
Contact: Jamileh Jafarbay 33-1-4122-5618
CHU Pitie-Salpetriere	Recruiting
Paris, France, 75651
Contact: Jean Philippe Spano 33-1-4216-0496
Hopital Bichat - Claude Bernard	Recruiting
Paris, France, 75018
Contact: Thomas Aparicio 33-1-4025-7200 thomas.aparicio@bch.ap-hop-paris.fr
Institut Sainte Catherine	Recruiting
Avignon, France, 84000
Contact: Sylvie Kirscher 33-4-9027-6265
Hopital Saint Antoine	Recruiting
Paris, France, 75571
Contact: Aimery de Gramont, MD 33-1-49-282-336 aimery.de-gramont@sat.ap-hop-paris.fr
Hopital Tenon	Recruiting
Paris, France, 75970
Contact: Jean-Pierre Lotz, MD 33-1-5601-6058 jean-pierre.lotz@tnn.ap-hop-paris.fr
Institut Jean Godinot	Recruiting
Reims, France, 51056
Contact: Herve Cure, MD, PhD 33-32-650-4482
Hopital Foch	Recruiting
Suresnes, France, 92151
Contact: May Mabro, MD 33-1-4625-2168 m.mabro@hopital-foch.org

Sponsors and Collaborators

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Study Chair:

Elisabeth Carola, MD

C.H. Senlis

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000593133, GERCOR-OLD07-SA07-1, EudraCT-2007004103-36
Study First Received:	April 22, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00664911
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer
stage IV colon cancer
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
stage IV rectal cancer

stage III ovarian epithelial cancer
stage III ovarian germ cell tumor
adenocarcinoma of the colon
adenocarcinoma of the rectum

Study placed in the following topic categories:

Gastrointestinal Diseases
Rectal Neoplasms
Gonadal Disorders
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Rectal Diseases
Genital Diseases, Female
Oxaliplatin
Rectal cancer
Breast Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Capecitabine

Digestive System Neoplasms
Ovarian Neoplasms
Skin Diseases
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Carboplatin
Intestinal Diseases
Doxorubicin
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Paclitaxel
Fluorouracil
Gastrointestinal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009