Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00372424
First received: September 5, 2006
Last updated: December 21, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Herceptin Drug: Sunitinib Drug: Taxotere |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Explorative Study Of The Tolerability Of SU011248 In Combination With Docetaxel And Trastuzumab As First-Line Treatment In Patients With Breast Cancer Over-Expressing HER-2 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: From screening until 28 days post last dose of study drug ] [ Designated as safety issue: Yes ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Secondary Outcome Measures:
- Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344) ] [ Designated as safety issue: No ]Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
- Progression-free Survival (PFS) [ Time Frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344) ] [ Designated as safety issue: No ]Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
- Duration of Response (DR) [ Time Frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344) ] [ Designated as safety issue: No ]Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
- Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) [ Time Frame: Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1 ] [ Designated as safety issue: No ]Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.
- Maximum Observed Plasma Concentration (Cmax) of Docetaxel [ Time Frame: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6 ] [ Designated as safety issue: No ]Concentration values below the lower limit of quantification were taken as zero.
- Plasma Trough Concentrations (Ctrough) of Trastuzumab [ Time Frame: Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6 ] [ Designated as safety issue: No ]Ctrough = the concentration prior to study medication administration.
Other Outcome Measures:
- Maximum Observed Plasma Concentration (Cmax) of Paclitaxel [ Time Frame: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | December 2006 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Combination of SU011248 (37.5 mg once daily [Schedule 2/1]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)
|
Drug: Herceptin
Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.
Other Name: trastuzumab
Drug: Sunitinib
SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.
Other Name: Sutent
Drug: Taxotere
The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.
Other Name: docetaxel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
- Tumors over-expressing Her-2
- Candidate for treatment with docetaxel/trastuzumab
Exclusion Criteria:
- Histology of inflammatory carcinoma
- AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372424
Locations
| Belgium | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1000 | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1200 | |
| Pfizer Investigational Site | |
| Charleroi, Belgium, 6000 | |
| Pfizer Investigational Site | |
| Sint-Niklaas, Belgium, 9100 | |
| Pfizer Investigational Site | |
| Wilrijk, Belgium, 2610 | |
| Italy | |
| Pfizer Investigational Site | |
| Meldola, FC, Italy, 47014 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20132 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00372424 History of Changes |
| Other Study ID Numbers: | A6181113 |
| Study First Received: | September 5, 2006 |
| Results First Received: | September 28, 2012 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Breast cancer over-expressing HER2. First-line treatment with sunitinib/docetaxel/trastuzumab. |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel Trastuzumab Sunitinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013