Cancer of the Fallopian Tube Clinical Trial
Official title:
Phase II Trial in Platinum-refractory Ovarian Cancer: A Randomized Multicenter Trial With SU11248 to Evaluate Dosage, Tolerability, Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor Monotherapy
Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic
strategies consist of a platinum containing chemotherapy subsequent to primary surgery.
Although initially responsive to platinum-paclitaxel containing chemotherapy, a significant
number of patients will show tumor progression during first line chemotherapy or relapse
within six months after completion of first line chemotherapy, therefore being characterized
as chemotherapy resistant. Any second line chemotherapy will result in approximately 10% of
overall response, underlining the poor prognosis for these patients with an estimated median
overall survival of 20 weeks.
In addition to conventional chemotherapeutics, so called small molecules are of high
interest to establish new strategies in chemotherapy-refractory ovarian cancer (and in the
long run first line chemotherapy). SU11248 is a polytargeting tyrosine kinase inhibitor.
SU11248 has demonstrated clinical efficacy in kidney cancer and GIST, further clinical
trials have been initiated in other tumor entities. Growth pattern and biological targets
present in ovarian cancer indicate that SU11248 might be a promising compound for the
treatment of ovarian cancer. Especially, VEGFR, PDGFR and c-kit are specific targets for
SU11248, which are expressed in ovarian cancer. The different targets of SU11248 provide a
potential advantage of this compound compared to single-target molecules in
chemotherapy-refractory ovarian cancer.
This study in patients with ovarian cancer refractory to platinum based chemotherapy is
designed as a randomized, 2-schedule and dose-level, open-label, multicenter phase II study
to select the better dose and schedule arm for further investigation.
72 patients will be randomized in a 1:1 ratio to receive oral SU11248 therapy either 37.5
mg/day continuously or 50mg/day for 4 weeks followed by 14 days off.
Patients will get outpatients treatment. At screening the patients' eligibility will be
assessed, their baseline and demographic characteristics obtained, and the baseline values
for the effect variables collected. Patients with measurable lesions as well as
non-measurable disease will be included into this trial. Measurable lesion will be
documented by CT or MRI scan and CA-125 values, non-measurable lesions will be monitored by
analysis of CA°125 levels.
The patients' safety will be monitored during and up to 30 days after termination of SU11248
therapy.
In patients with measurable lesions at baseline, the (post)-treatment values for effect
according to the RECIST criteria will be collected as shown in table 6. In case of CR or PR,
a confirmatory CT or MRI scan is required after an interval of at least four weeks.
Antitumor effects according to CA°125 levels will be determined in the same time intervals
and, in addition, 28 days after last SU11248 application in patients with CA°125 response
according to GCIG guidelines during therapy.
For post study follow-up, patients and/or their physicians will be contacted via phone for
overall survival and TTP (including the method of diagnosis and additional treatment) every
2 months for their life time.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02728622 -
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane
|
Phase 3 | |
| Completed |
NCT00189358 -
A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy
|
Phase 2 |