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Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Gemcitabine (Drug); Herceptin (Drug); Capecitabine (Xeloda) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Hellenic Oncology Research Group

Official(s) and/or principal investigator(s):
Dimitris Mavrudis, MD, Principal Investigator, Affiliation: University Hospital of Crete

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to progression (TTP) between the two treatment arms

Secondary outcome:

Overall survival

Toxicity profile

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

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

Locations and Contacts

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece

"Marika Iliadis" Hospital of Athens, 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

Additional Information

Starting date: April 2003
Last updated: February 12, 2013

Page last updated: August 23, 2015

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