A Trial of Gemcitabine Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00192062
First received: September 12, 2005
Last updated: August 29, 2007
Last verified: August 2007
  Purpose

This is a Phase II study of gemcitabine- Vinorelbine combination in a 3-weekly schedule as first line chemotherapy in patients with metastatic breast cancer. Eighty patients with measurable disease will be enrolled in the study. Gemcitabine will be used at 1000 mg/m2, vinorelbine at 25mg/m2. Every cycle, vinorelbine will be administered before gemcitabine. After the initial dose, modifications of Gemcitabine and vinorelbine doses are allowed based on patient toxicity

Study therapy may continue until:

  • There is evidence of progressive disease
  • The patient experiences unacceptable toxicity.
  • The investigator decides that the patient should be discontinued
  • The patient requests discontinuation
  • The patient has received 6 cycles of the regimen(if the physician decides to continue after 6 cycles-this will be done after consultation with the sponsor)
  • Discontinuation from study therapy is indicated according to the protocol It's the investigator's responsibility to strictly stick to the protocol procedures. It needs to be discussed with Lilly medical designee in advance when any special situation occurs which has not been defined in protocol.

After patients discontinue from study therapy, they proceed to the post-study follow up phase of the study. Assessments to take place during this phase are outlined in the protocol.


Condition Intervention Phase
Breast Cancer
Drug: gemcitabine
Drug: vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine (Gemzar) Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To evaluate the response rate of Gemcitabine-vinorelbine when used in a 3-weekly as first line chemotherapy in patients with metastatic breast cancer.

Secondary Outcome Measures:
  • To characterize the quantitative and qualitative toxicity of Gemcitabine-vinorelbine patient population
  • Relative dose density of Gemcitabine and vinorelbine
  • Rate of dose modifications (admissions, reductions, delays)
  • Time to progression
  • Duration of response
  • 1 year survival

Estimated Enrollment: 80
Study Start Date: July 2004
Study Completion Date: June 2007
  Eligibility

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

Inclusion Criteria-

  • Histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. Lesions should not be amenable to surgery or radiation of curative intent.
  • Presence of metastatic or local-regional recurrent disease, according to the American Joint Committee on Cancer (Greenz, et al, 2002).
  • Uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (CT), Chest x-ray or clinical examination, according to RECIST criteria (Therasse, et al, 2002).
  • No prior chemotherapy for metastatic or locoregionally recurrent disease. Prior adjuvant or neoadjuvant chemotherapy with Anthracyclines based regimen is mandatory. The time from the last dose of prior adjuvant chemotherapy and study entry must be at least 30 days and patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
  • Prior radiotherapy must be completed at least 30 days before study entry.
  • No concurrent hormonal therapy for MBC. Prior hormonal therapy is allowed, the time from the last dose of prior hormonal therapy for breast cancer to study enrollment must be at least 1 week.

Exclusion Criteria -

  • Have received treatment within the last 30 days with an investigational drug for any indication before study entry.
  • Concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including Herceptin).
  • Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
  • Pregnancy or breast-feeding.
  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192062

Locations
Egypt
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Alexandria, Egypt
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Assyout, Egypt
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Cairo, Egypt
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Giza, Egypt
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00192062     History of Changes
Other Study ID Numbers: 7775, B9E-EY-S372
Study First Received: September 12, 2005
Last Updated: August 29, 2007
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 28, 2014