Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: docetaxel Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer |
| Study Start Date: | May 2000 |
OBJECTIVES:
- Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel.
- Compare the toxicities and pharmacoeconomics of these four regimens in these patients.
- Compare the quality of life of patients treated with these four regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no).
Patients are randomized to one of four treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1.
- Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
- Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
- Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to treatment and then every 8 weeks.
PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven unresectable locally advanced or metastatic breast cancer
- Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines
- At least one bidimensionally measurable lesion
- No brain metastasis
- No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease
Hormone receptor status:
- Known hormone receptor status
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- Bilirubin normal
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No uncontrolled angina or arrhythmia
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart disease
Other:
- No sensitive neuropathy worse than grade 2
- No other significant, uncontrolled medical or psychiatric condition
- No serious active infection
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior specific antitumoral immunotherapy
Chemotherapy:
- See Disease Characteristics
- No prior taxanes
- At least 4 weeks since other prior specific antitumoral chemotherapy
Endocrine therapy:
- At least 4 weeks since prior specific antitumoral hormonal therapy
Radiotherapy:
- At least 4 weeks since prior specific antitumoral radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent experimental medication
Contacts and Locations| France | |
| Centre Hospitalier d'Antibes | |
| Antibes, France, 06606 | |
| Centre Hospitalier Victor Dupouy | |
| Argenteuil, France, 95107 | |
| Institut Sainte Catherine | |
| Avignon, France, 84082 | |
| Clinique Floreal | |
| Bagnolet, France, 28630 | |
| Centre D'Oncologie Du Pays-Basque | |
| Bayonne, France, F-64100 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| Hopital Fontenoy | |
| Chartres, France, 28018 | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Hopital Louis Mourier | |
| Colombes, France | |
| Centre Hospitalier Laennec | |
| Creil, France, 60109 | |
| Hopital Intercommunal De Creteil | |
| Creteil, France, 94010 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie | |
| Gien, France, 45500 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Hopital Desgenettes - Service de Medecine Interne | |
| Lyon, France, 69998 | |
| Centre de Radiotherapie et Oncologie Saint-Faron | |
| Mareuil Les Meaux, France, 77100 | |
| Hopital Saint Joseph | |
| Marseille, France, 13008 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 57038 | |
| CH Meulan | |
| Meulan, France, 78250 | |
| Intercommunal Hospital | |
| Montfermeil, France, 93370 | |
| Centre Hospitalier de Mulhouse | |
| Mulhouse, France, 68051 | |
| American Hospital of Paris | |
| Neuilly Sur Seine, France, F-92202 | |
| Clinique Hartmann | |
| Neuilly sur Seine, France, 92200 | |
| Clinique Geoffroy St. Hillaire | |
| Paris, France, 75005 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hotel Dieu de Paris | |
| Paris, France, 75181 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95301 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Centre du Rouget | |
| Sarcelles, France, 95250 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Clinique de l'Orangerie | |
| Strasbourg, France, 67010 | |
| Clinique Pasteur | |
| Toulouse, France, 31076 | |
| Clinique Fleming | |
| Tours, France, 37000 | |
| Luxembourg | |
| Hopital de la Ville D'Esch-sur-Alzette | |
| Esch-sur-Alzette, Luxembourg, L-4005 | |
| Study Chair: | Joseph Gligorov, MD | Hopital Tenon |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006120 History of Changes |
| Other Study ID Numbers: | CDR0000068134, FRE-GERCOR-TAXMAX-SOO-1, EU-20029 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Docetaxel Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013