Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer

NCT00201760 | Completed Phase 2 Results DMC

• 1 other identifier: OSU-0342
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study determines the proportion of metastatic breast cancer patients progression free after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/ trastuzumab.

Conditions

Breast Cancer

Keywords

metastatic

Outcome Measures

Primary Outcomes (1)

• Disease Progression

  Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment

  6 months

Secondary Outcomes (2)

• Measure Response Rate of Each Drug Combination

  Up to 24 months

• Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations

  Up to 24 months

Study Arms (2)

Arm 1 Gemcitabine/Cisplatin/Trastuzumab

EXPERIMENTAL

Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).

Drug: Gemcitabine; Drug: Trastuzumab; Drug: Cisplatin

Arm 2 Gemcitabine / Trastuzumab

ACTIVE COMPARATOR

Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).

Drug: Gemcitabine; Drug: Trastuzumab

Interventions

Gemcitabine DRUG

1000 mg/m2 IV over 30 minutes on Days 1 and 8.

Also known as: Gemzar

Arm 1 Gemcitabine/Cisplatin/Trastuzumab; Arm 2 Gemcitabine / Trastuzumab

Trastuzumab DRUG

2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.

Also known as: Herceptin

Arm 1 Gemcitabine/Cisplatin/Trastuzumab; Arm 2 Gemcitabine / Trastuzumab

Cisplatin DRUG

30 mg/m2 IV on Day 1 and Day 8.

Also known as: Platinol®-AQ, CDDP

Arm 1 Gemcitabine/Cisplatin/Trastuzumab

Eligibility Criteria

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

Eligibility Criteria: * Must have invasive metastatic breast cancer * Tumor must be Her 2/neu 3+ by IHC (must be confirmed by Ohio State University pathology)or positive FISH * Histological confirmation of invasive breast cancer either from the original diagnosis and/or diagnosis of metastatic disease. * Tumor must be detectable clinically or radiographically (a positive bone scan is allowed as the only site of disease). Unidimensional measurements must be obtained whenever possible). Bone marrow only disease is not eligible for enrollment on this study. * No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, or evidence of prior myocardial infarction on EKG or ECHO. Patients must have normal LV function and LVEF(left ventricular ejection fraction)\> 50% as demonstrated by either echo or muga within the proceeding 4 weeks. * Must have adequate renal and hepatic function documented by a serum creatinine \< 1.5 x the institutional upper limit of normal (ULN), serum bilirubin \<1.5 x ULN and liver enzymes (AST, ALT, or alkaline phosphatase) \< 2 x ULN (\< 5 x ULN if hepatic metastasis) within 21 days prior to registration. * Patients must have an ANC (absolute neutrophil count) \> 1.5, platelets \> 100,000, Hemoglobin \>9.0 within 21 days of registration. * If patients are on bisphosphonates at the time of registration, with a stable creatinine over the preceding 2 months, then they may continue bisphosphonates during the study. * No more than one prior Trastuzumab/chemotherapy or Trastuzumab/biotherapy combination for metastatic disease. Additional Trastuzumab therapy may have been given in the adjuvant setting. Prior hormonal therapy is allowed for either adjuvant or metastatic disease. * Must be \>3 weeks since administration of last chemotherapy prior to initiation of treatment on this trial. Prior trastuzumab may have been administered within one week of initiation of treatment on this trial if the last dose was 2 mg/kg. Any prior trastuzumab dosing greater than 2 mg/kg requires a 3 week washout period. * Patients may have received prior cisplatin or carboplatin for metastatic disease. * No CNS(central nervous system)metastasis disease. * No active infection at time of registration. * Pregnant or nursing women may not participate in trial. * Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines. * ECOG (Eastern Cooperative Oncology Group)performance status \< 2 at the time of registration. * Patients may participate in a non-treatment related protocol while participating in this study. * No other active malignancy is allowed. Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years is allowed.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kari Kendra: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.

  PMID: 33084020 DERIVED

Related Links

• Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Gemcitabine; Trastuzumab; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Kari Kendra, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Kari.Kendra@osumc.edu

614-293-7956

Study Officials

• Kari Kendra, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: February 25, 2005
• Primary Completion: October 31, 2009
• Study Completion: October 31, 2009
• Last Updated: December 27, 2017
• Results First Posted: November 9, 2017

Record last verified: 2017-11

Locations

US (1)