Phase II Study of Gemcitabine/Vinorelbine vs Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer

June 24, 2011 updated by: National Cancer Center, Korea

A Phase II Study of Gemcitabine in Combination With Vinorelbine vs. Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer

To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with stage IV and recurrent breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, randomized, two-arm, parallel group phase II study. Eligible patients will be randomized to each of the two treatment regimens, one of which is gemcitabine and vinorelbine combination therapy (Group A) and the other is gemcitabine monotherapy followed by vinorelbine monotherapy (Group B). Patients In group A monotherapy will receive gemcitabine and vinorelbine in combination, while patients in group B will receive gemcitabine monotherapy until the evidence of disease progression followed by vinorelbine. A total of 82 patients will be enrolled in this study. Patients will be randomized after stratified according to the number of prior chemotherapy including adjuvant chemotherapy and visceral disease. No maximum number of cycles is pre-determined. Patients may continue on study therapy until documented treatment failure.

Patients in group A who discontinue study therapy will proceed to the post-therapy follow-up phase of the study. Patients in group B who discontinue study therapy while treated with gemcitabine will proceed to receive vinorelbine on disease progression. Patients on vinorelbine who discontinue study therapy will proceed to the post-therapy follow-up phase of the study. Further treatment upon discontinuation of study therapy is at the discretion of the investigator.

A two arm, open label phase II study without control is appropriate for exploring the efficacy of gemcitabine with concurrent or sequential vinorelbine in this patient population and for evaluating and characterizing toxicities of two treatment approaches, qualitatively and quantitatively. The purpose of randomization in this phase II study is to diminish the possible impact of selection bias on treatment outcome and thus on interpretation of efficacy and safety data.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologic or cytologic diagnosis of stage IV or recurrent breast cancer.
  • Previous anthracycline and/or taxane and/or capecitabine chemotherapy in adjuvant and metastatic setting.
  • Previous hormonal therapy in adjuvant and metastatic setting.
  • Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
  • No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.
  • Performance status of 0, 1, 2 on the ECOG criteria.
  • Clinically measurable disease, defined as unidimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1cm by 1cm, as defined by x-ray, CT scan, MRI,or physical examination.
  • Estimated life expectancy of at least 12 weeks.
  • Patient compliance that allow adequate follow-up.
  • Adequate hematologic (WBC count3,000/mm3, platelet count100,000/mm3), hepatic (bilirubin level1.5 mg/dL, AST, ALT3xULN), and renal (creatinine concentration 1.5 mg/dL) function.
  • Informed consent from patient or patient's relative.
  • Females at least 18 years of age.
  • Childbearing women should use non-hormonal contraceptive method.

Exclusion Criteria:

  • Previous chemotherapy > 3 for recurrent or stage IV disease Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
  • Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combination
Drug: Gemcitabine plus Vinorelbine
Gemcitabine, 1,000mg/m2 and Vinorelbine, 25mg/m2, on day 1 and day 8, every 3 week cycles
Other Names:
  • Navelbine
  • Gemzar
Active Comparator: Seqeuntial

Gemcitabine monotherapy followed by Vinorelbine monotherapy:

-Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles.
Drug: Sequential

Gemcitabine monotherapy followed by Vinorelbine monotherapy:

-Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles.

Other Names:
  • Navelbine
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall response rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Jungsil Ro, MD, PhD, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 24, 2011

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-04-092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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