|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01454479 |
|
Date of registration:
|
28/09/2011 |
|
Primary sponsor: |
|
|
Public title:
|
A Phase I Study of Lapatinib (Tykerb) Plus Ixabepilone (Ixempra) as 2nd-line Treatment for Patients With HER-2 Overexpressed Recurrent or Persistent Endometrial Carcinoma or Carcinosarcoma
|
|
Scientific title:
|
A Phase I Study of Lapatinib (Tykerb) Plus Ixabepilone (Ixempra) as 2nd-line Treatment for Patients With HER-2 Overexpressed Recurrent or Persistent Endometrial Carcinoma or Carcinosarcoma |
|
Date of first enrolment:
|
March 2011 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
http://clinicaltrials.gov/show/NCT01454479 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Histologically confirmed carcinoma or carcinosarcoma of the endometrium with evidence
of persistent disease or progression after initial surgery and adjuvant chemotherapy,
radiotherapy, or both, not amenable for curative salvage therapy.
2. ErbB2 gene amplification by FISH (ErbB2 gene copies to chromosome 17 signals) of > =
2.0; ErbB2 overexpression is defined by immunostaining >=2 for ErB2
3. Measurable disease, defined as =1 lesions that can be accurately measured in
- 1 dimensions as =20 mm by conventional techniques OR as =10 mm by spiral CT
scan, MRI or PET scan (those who undergo cytoreductive salvage surgery with
residual tumor = 20 mm are eligible)
4. Those who are chemotherapy-naive be enrolled until failing one chemotherapy regimen
5. Prior treatments with radiation therapy for palliative management of metastatic
disease is permitted provided that at least 4 weeks have elapsed since the last
fraction of radiation therapy, disease progression has been documented and all
treatment related adverse events are ? grade 2 at the time of registration.
6. Life expectancy = 12 weeks
7. ECOG(Eastern Cooperative Oncology Group) performance status 0-2
8. Patients must have normal organ and marrow function measured within 14 days
Exclusion Criteria:
1. Previously unirradiated, isolated vaginal, pelvic or paraaortic lymph node, lung
(which confined to one lobe that can be resected or radiated) recurrence or other
potentially curable recurrence such as central pelvic recurrence for which a pelvic
exenteration is feasible
2. Pregnant or lactating women.
3. Subjects who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable
chronic liver disease per investigator assessment)
4. Prior therapy with Lapatinib or Ixabepilone.
5. CNS metastases.
6. Ongoing other concurrent investigational agents or anticancer therapy
7. Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, serious non- healing wound/ulcer/bone fracture,
or psychiatric illness/social situations that would limit compliance with study
requirements.
8. 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, ulcerative
colitis).
9. Preexisting peripheral neuropathy=G2
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Recurrent Endometrial Cancer
|
|
Intervention(s)
|
|
Drug: Lapatinib and ixempra
|
|
Primary Outcome(s)
|
|
Determine the Maximum Tolerated Dosage (MTD) of the combination of lapatinib with Ixabepilone as 2nd-line chemotherapy in patients with treatment in HER2 overexpressed recurrent or persistent endometrial cancer or carcinosarcoma
[Time Frame: 2013/Apr]
|
|
Secondary ID(s)
|
|
99-3771A3
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|