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

NCT00532623 | Completed Phase 2

• 1 other identifier: NCCCTS-04-092
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• overall response rate

  3 years

Study Arms (2)

Combination

ACTIVE COMPARATOR

Drug: Gemcitabine plus Vinorelbine

Seqeuntial

ACTIVE COMPARATOR

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

Interventions

Gemcitabine plus Vinorelbine DRUG

Gemcitabine, 1,000mg/m2 and Vinorelbine, 25mg/m2, on day 1 and day 8, every 3 week cycles

Also known as: Gemzar, Navelbine

Combination

Sequential DRUG

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.

Also known as: Gemzar, Navelbine

Seqeuntial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Center, Korea: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Jungsil Ro, MD, PhD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 20, 2007
• Study Start: May 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: October 1, 2006
• Last Updated: June 27, 2011

Record last verified: 2007-09