Phase Ib/II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Sunitinib

NCT01070706 | Completed Phase 1

• 1 other identifier: NCCCTS-08-369
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Phase Ib part: ▪ Primary objective: To demonstrate the recommended dose of the combination of paclitaxel, gemcitabine, and sunitinib (sutene®) (PGS) as preoperative chemotherapy in patients with HER2-negative operable breast cancer

1. 1.To demonstrate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of this regimen
2. 2.To determine the safety profile
3. 3.Primary objective: To evaluate the pathologic complete response rate (pCR) to preoperative administration of PGS ▪ Secondary objective:
4. 4.To assess breast conserving rate after preoperative PGS
5. 5.To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS)
6. 6.To assess the safety profiles of PGS

Conditions

Breast Cancer

Keywords

Patients with HER2- stage II/III breast cancer

Outcome Measures

Primary Outcomes (1)

• Phase Ib part: To demonstrate the recommended dose of the combination of paclitaxel, gemcitabine, and sunitinib. Phase II part: To evaluate the pathologic complete response rate (pCR)

  17Mar2009~08Apr2010

Study Arms (1)

Paclitaxel, Gemcitabine, Sunitinib

EXPERIMENTAL

Paclitaxel, Gemcitabine, Sunitinib

Drug: Paclitaxel,Gemcitabine,Sunitinib

Interventions

Paclitaxel,Gemcitabine,Sunitinib DRUG

To determine the MTD, only DLT occurring during the first cycle of treatment will be considered. And MTD is defined as the dose level at which at least one-third of patients experience a DLT during their first treatment course. The recommended dose level for the subsequent phase II study is defined as the preceding dose level before the MTD is attained. If MTD is not reached, the recommended initial dose of the phase II part will be at the dose of paclitaxel 80 mg/m2 and gemcitabine 1200 mg/m2 (days 1, 8) with sunitinib 37.5 mg qd D2-D15.

Also known as: PGS

Paclitaxel, Gemcitabine, Sunitinib

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• ECOG performance status 0-2
• Histologically confirmed and newly diagnosed breast cancer
• Documented HER2/neu non-overexpressing or non-amplified disease
• + by HER2 IHC or
• HER2 gene non-amplification by HER2 FISH
• Clinical stage II or III operable breast cancer
• Axillary node positivity determined by cytology
• No prior hormonal, chemotherapy or radiotherapy is allowed
• No breast operation other than biopsy to make diagnosis is allowed
• Adequate hematologic, hepatic and renal function
• Absolute neutrophil count ≥ 1,500/μL
• Hemoglobin ≥ 10.0 g/dL
• Platelet ≥ 100,000/μL
• AST/ALT ≤ 2 X UNL (upper limit of normal)

You may not qualify if:

• Patients with metastatic breast cancer
• Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
• Patients who underwent surgery for breast cancer
• Patients with T2N0, or inflammatory (T4d) breast cancer
• Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
• Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis)
• Any of the following within the 12 months prior to starting study treatment
• severe, unstable angina
• Myocardial infarction
• Uncontrolled or symptomatic congestive heart failure
• coronary/peripheral artery bypass graft
• cerebrovascular accident including transient ischemic attack
• pulmonary embolism
• Ongoing cardiac dysrhythmias of grade ≥2, atrial fibrillation of any grade, or QTc interval \>470 msec.
• Hypertension that cannot be controlled by medications (\>150/100 mmHg despite optimal medical therapy)

Sponsors & Collaborators

• Jungsil Ro: lead
• Pfizer: collaborator
• HK inno.N Corporation: collaborator

Study Sites (1)

Center for breast cancer, National Cancer Center

Goyang, Kyeonggido, 410-769, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jungsil Ro

  Chief, Center for Breast Cancer, National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Center for Clinical Trials, National Cancer Center, Korea

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: November 1, 2010
• Last Updated: January 4, 2012

Record last verified: 2012-01

Locations

KR (1)