Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
This study has been terminated.
(Due to poor accrual)
Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00440622
First received: February 26, 2007
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Gemcitabine Drug: Herceptin Drug: Capecitabine (Xeloda) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Hellenic Oncology Research Group:
Primary Outcome Measures:
- Time to progression (TTP) between the two treatment arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity profile [ Time Frame: During the time of chemotherpy ] [ Designated as safety issue: Yes ]
| Enrollment: | 90 |
| Study Start Date: | April 2003 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
GHer
|
Drug: Gemcitabine
Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
Other Name: Gemzar
Drug: Herceptin
Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV
Other Name: Herceptin
|
|
Experimental: 2
CapHer
|
Drug: Herceptin
Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV
Other Name: Herceptin
Drug: Capecitabine (Xeloda)
Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles
Other Name: Xeloda
|
Detailed Description:
This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine (Xeloda) plus Herceptin in pretreated patients with metastatic HER-2 positive breast cancer.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent
- Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
- HER-2 overexpression 2+ or 3+ using IHC or FISH +
- Measurable disease
- At least one prior chemotherapy regimen
- Not in a prior irradiation field
- No patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
- No more than 25% of myeloproductive bone marrow irradiated. More than 4 weeks since prior radiotherapy and recovered
- Age 18 - 75 year old
- Performance status (WHO) 0-2
- Life expectancy more than 12 weeks
- Absolute neutrophil count > 1500/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
- Adequate liver (bilirubin < 2 mg/dL, SGOT/SGPT < 2 times upper limit of normal, ALP < 3 times upper limit of normal, creatinine < 1.5 upper limit of normal
- Adequate cardiac function (LVEF > 50%)
Exclusion Criteria:
- Pregnant or nursing
- Positive pregnancy test
- Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
- Motor or sensory neuropathy > grade 1 according to NCIC toxicity criteria
- History of allergic reaction attributed to docetaxel
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness
- Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440622
Locations
| Greece | |
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | |
| Alexandroupolis, Greece | |
| "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology | |
| Athens, Greece | |
| "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | |
| Athens, Greece | |
| "IASO" General Hospital of Athens, 1st Dep of Medical Oncology | |
| Athens, Greece | |
| 401 Military Hospital of Athens | |
| Athens, Greece | |
| Air Forces Military Hospital of Athens | |
| Athens, Greece | |
| State General Hospital of Larissa, Dep of Medical Oncology | |
| Larissa, Greece | |
| "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology | |
| Piraeus, Greece | |
| "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | |
| Thessaloniki, Greece | |
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
| Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Crete |
More Information
No publications provided
| Responsible Party: | Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00440622 History of Changes |
| Other Study ID Numbers: | CT/03.09 |
| Study First Received: | February 26, 2007 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Hellenic Oncology Research Group:
|
Cancer Metastatic Breast cancer Her-2 expression |
Gemcitabine Capecitabine Herceptin |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Capecitabine Fluorouracil Trastuzumab 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 |
ClinicalTrials.gov processed this record on May 22, 2013