Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer. - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191789

Purpose

Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.

Condition	Intervention	Phase
Breast Cancer	Drug: gemcitabine Drug: doxorubicin Drug: cisplatin Procedure: surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Neoadjuvant Administration of Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Large or Locally Advanced Operable Breast Cancer: A Phase II Study.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride Gemcitabine Myocet Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
Time to treatment failure [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]

Enrollment:	65
Study Start Date:	February 2003
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: gemcitabine 1200 mg/m2, IV day 1 and day 8 q 21 days x 4 cycles (1-4) then 1000 mg/m2, IV, day 1 and day 8 q 21 days x 4 cycles (5-8) Drug: doxorubicin 60 mg/m2, IV, q 21 days x 4 cycles (1-4) Drug: cisplatin 70 mg/m2, IV, q 21 days x 4 cycles (5-8) Procedure: surgery Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision

Arms

Assigned Interventions

A: Experimental

Drug: gemcitabine

1200 mg/m2, IV day 1 and day 8 q 21 days x 4 cycles (1-4) then 1000 mg/m2, IV, day 1 and day 8 q 21 days x 4 cycles (5-8)

Drug: doxorubicin

60 mg/m2, IV, q 21 days x 4 cycles (1-4)

Drug: cisplatin

70 mg/m2, IV, q 21 days x 4 cycles (5-8)

Procedure: surgery

Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of breast carcinoma
No previous chemotherapy, with bidimensionally measurable locally advanced disease
Adequate performance status (KPS greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.

Exclusion Criteria:

Inflammatory breast cancer
Pregnancy & Breast-feeding
Serious concomitant disorder or infection
Previous cancer within the last 5 years or a second primary malignancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191789

Locations

India
For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician.
Delhi, India, 110029
India, Maharashtra
For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician.
Pune, Maharashtra, India, 411001
India, Tamil Nadu
For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician.
Vellore, Tamil Nadu, India, 632004

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT -5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	7117, B9E-MC-S329
Study First Received:	September 12, 2005
Last Updated:	May 26, 2009
ClinicalTrials.gov Identifier:	NCT00191789 History of Changes
Health Authority:	India: Ministry of Health

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Skin Diseases
Immunologic Factors
Breast Neoplasms
Antiviral Agents
Immunosuppressive Agents

Doxorubicin
Anti-Bacterial Agents
Cisplatin
Radiation-Sensitizing Agents
Gemcitabine
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Enzyme Inhibitors
Antibiotics, Antineoplastic

Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine
Breast Diseases

ClinicalTrials.gov processed this record on September 02, 2009