Status:
UNKNOWN
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
Lead Sponsor:
Hung-Hsueh Chou
Collaborating Sponsors:
GlaxoSmithKline
Bristol-Myers Squibb
Conditions:
Recurrent Endometrial Cancer
Eligibility:
FEMALE
20-75 years
Phase:
PHASE1
Brief Summary
Endometrial cancer (EC) is the 8th most common female cancer in Taiwan. Its incidence is increasing in the recent few years, around 1,200 new cases per year. The outcome of recurrent EC is disappointi...
Detailed Description
Patients receive weekly Ixabepilone 32 mg/m2 (D1) and a 4-level of oral Lapatinib 500-1250 mg once daily continuously. The recommended duration of treatment for each patient 21 days a cycle of total 6...
Eligibility Criteria
Inclusion
- 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.
- ErbB2 gene amplification by FISH (ErbB2 gene copies to chromosome 17 signals) of \> = 2.0; ErbB2 overexpression is defined by immunostaining \>=2 for ErB2
- 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)
- Those who are chemotherapy-naive be enrolled until failing one chemotherapy regimen
- 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.
- Life expectancy ≥ 12 weeks
- ECOG(Eastern Cooperative Oncology Group) performance status 0-2
- Patients must have normal organ and marrow function measured within 14 days
Exclusion
- 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
- Pregnant or lactating women.
- 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)
- Prior therapy with Lapatinib or Ixabepilone.
- CNS metastases.
- Ongoing other concurrent investigational agents or anticancer therapy
- 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.
- 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).
- Preexisting peripheral neuropathy≥G2
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01454479
Start Date
March 1 2011
End Date
April 1 2014
Last Update
October 19 2011
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