Phase IB/II Trial Combining Vinorelbine With Sorafenib as First-Line Treatment in Patients With Metastatic Breast Cancer

NCT00764972 | Unknown Phase 1 DMC

• 1 other identifier: McG 0713
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast cancer. The investigators are combining these 2 drugs in order to determine if the investigators can increase the activity of vinorelbine in metastatic breast cancer patients. Patients with measurable metastatic breast cancer without previous chemotherapy for metastatic disease are eligible for the protocol. They will be treated with 2 different dose levels of sorafenib in order to determine the most tolerable dose.

Conditions

Metastatic Breast Cancer

Keywords

To evaluate the use of sorafenib added to vinorelbine chemotherapy, to find out which are the doses of two drugs can be safely combined

Outcome Measures

Primary Outcomes (1)

• Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.

Study Arms (1)

Sorafenib and Vinorelbine

EXPERIMENTAL

Drug: Sorafenib and Vinorelbine

Interventions

Sorafenib and Vinorelbine DRUG

vinorelbine, administered as a brief infusion twice every three weeks (on day 1 and 8 of 21-day cycles); sorafenib, that you will take orally every day, at the dosage that your study doctor will prescribe.

Also known as: BAY 43-9006

Sorafenib and Vinorelbine

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women affected by histologically proven metastatic breast cancer.
• Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification or immunohistochemistry 0-1+ for HER-2 expression.
• Female, age ≥ 18.
• Documented measurable disease by appropriate radiologic imaging according to RECIST criteria (see Appendix E). Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation.
• ECOG performance status 0-1 (see Appendix B)
• Life expectancy \> 6 months.
• Adequate bone marrow function, as indicated by:
• Hemoglobin ≥ 90 g/L
• Neutrophils ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Adequate renal function, as indicated by serum creatinine ≤1.5 times the upper limit of normal and/or Creatinine Clearance calculated as \>50% lower normal limit, or estimated as ≥ 50 ml/min (Appendix C).
• Adequate liver function, as indicated by:
• bilirubin ≤ 1.5 times upper normal limit;
• AST and ALT ≤ 2 times upper normal limit.
• Left ventricular ejection fraction (LVEF) ≥50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECHO).

You may not qualify if:

• Patients with locally advanced breast cancer or stage IIIb only.
• Presence of only non-measurable disease.
• Previous (neo)adjuvant chemotherapy with vinorelbine.
• Any previous anti-angiogenic therapy.
• Any previous chemotherapy for metastatic breast cancer. Previous hormonal treatments or radiotherapy for metastatic disease are allowed.
• Radiotherapy, chemotherapy or hormonal therapy for breast cancer in the last 4 weeks prior to starting the study treatment.
• Major surgery within 4 weeks of first study treatment, or minor surgery (including placement of an access device) within 7 days of therapy start.
• Presence of life-threatening disease or central nervous system localizations.
• Evidence of HER-2 positive breast cancer, defined as FISH-positive for amplification or score 3+ by immunohistochemistry.
• Any other possibly active primary tumor, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
• Clinically significant hepatic disease with respect to hepatitis B, hepatitis C, cirrhosis or other liver diseases.
• Uncontrolled bacterial, viral or fungal infection.
• Previous history of ischemic disease.
• Patients with previous history of thrombo-embolic events, or with documented risk factors for thrombotic disease other than cancer.
• History of gross hemorrhage within the past 6 months (e.g., hemoptysis or hematuria requiring medical intervention).

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Related Publications (1)

• Ferrario C, Strepponi I, Esfahani K, Charamis H, Langleben A, Scarpi E, Nanni O, Miller WH Jr, Panasci LC. Phase I/II Trial of Sorafenib in Combination with Vinorelbine as First-Line Chemotherapy for Metastatic Breast Cancer. PLoS One. 2016 Dec 19;11(12):e0167906. doi: 10.1371/journal.pone.0167906. eCollection 2016.

  PMID: 27992451 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sorafenib; Vinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; 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

• Lawrence Panasci

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lawrence Panasci

CONTACT

514-340-8248; lpanasci@hotmail.com

Cristiano Ferrario

CONTACT

514-340-8248; cristianoferrario@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: October 21, 2008

Record last verified: 2008-10

Locations

CA (1)