Trial | NCT00532285  Report issue

Title

Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    44
This is an open labeled phase II single arm trial. The patients with clinical stage II and III will undergo core-needle biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu and others. PET or ultrasound results will determine the positivity of lymph node metastasis.
Patients will be treated as follows:

PG x 4®operation®AC x 4®radiation ± tamoxifen/AI(postmenopausal)

Intravenous infusion of Paclitaxel 80 mg/m2, over 60 min, on D1 and D8 Followed by intravenous infusion of Gemcitabine 1200 mg/m2, over 30 min, on D1 and D8

The cycle repeats every 3 weeks for 4 times. Premedication includes antiemetics, dexamethasone, famotidine, pheniramine as routinely given.

After the operation, standard adjuvant chemotherapy (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2, every 3 weeks x 4 cycles) will be given.
Study Started
Sep 30
2005
Primary Completion
Apr 30
2006
Study Completion
Aug 31
2009
Last Update
Jun 23
2011
Estimate

Drug Paclitaxel/Gemcitabine

Treatment will be delivered in the outpatient setting. Each three-week cycle consists of paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8).Patients will receive four cycles of therapy unless there is any evidence of no response (SD or PD) or unacceptable toxicity defined as unpredictable, irreversible, or Grade 4, or noncompliance by patient with protocol requirements.

  • Other names: Paclitaxel, Gemzar

Paclitaxel/Gemcitabine Experimental

paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles

Criteria 

Inclusion Criteria:

All patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage IIA and any stage IIB, III. PET results will determine node positivity. If PET was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration.
No prior hormonal, chemotherapy or radiotherapy is allowed.
No breast operation other than biopsy to make diagnosis is allowed.
Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
Adequate hematopoietic function: Absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3
Adequate renal function: Serum creatinine £ 1.5 mg/dl
Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ two times normal, Alkaline phosphatase: £ two times normal
Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment
Adequate mental function to understand and sign the consent

Exclusion Criteria:

Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
Patients who underwent surgery for breast cancer
Patients with node-negative stage IIA breast cancer
Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
No Results Posted