Platinum-resistant ovarian, fallopian tube or primary peritoneal cancer. The relevant MedDRA codes for recurrent ovarian cancer and fallopian tube cancer are given below. MedDRA version: 14.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1
Conditions
Interventions
Product Name: Paclitaxel
Pharmaceutical Form:
INN or Proposed INN: Paclitaxel
CAS Number: 33069-62-4
Current Sponsor code: PR1a
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed ovarian, fallopian tube or primary peritoneal cancer Confirmed relapsed disease AND relapse within the platinum-resistant (progression must not be based on CA125 alone) time-frame, i.e. have progressed within 6 months of platinum therapy. Relapse should ideally have been confirmed radiologically with measurable disease, but patients with CA125 progression plus symptoms indicative of progression will also be allowed to enter Patients with synchronous tumours e.g. ovarian and endometrial or history of prior malignancy are eligible provided that there is biopsy evidence that the disease measurable on CT and/or MRI is ovarian in origin. Patients must have archival formalin-fixed paraffin-embedded tissue (or cytological block) from their original diagnosis available for the purposes of translational research (see point sections 4.2 and 20.0) Patients need not have received prior taxane; if patients have received prior taxane, the interval since treatment must be known. Patients will be stratified as 1.5 x 109/l Platelet count > 100 x 109/l Hb > 9.0 g/dl Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Prior administration of weekly paclitaxel. Tumours of malignant mixed mesodermal (MMMT) or mucinous subtypes, or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours). Synchronous primary tumours e.g. ovarian and endometrial with no biopsy evidence of measurable disease of ovarian origin. Unresolved bowel obstruction. Chemotherapy within the preceding 3 weeks. Radiotherapy within the preceding 3 weeks. Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer. Known leptomeningeal involvement or intracranial disease. Evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease). Resting ECG with measurable QTc interval of >480 msec at 2 or more time points within a 24 hour period. Pregnant or lactating females. Fertile women of childbearing potential not willing to use highly effective contraception for the duration of trial treatment and for at least 6 months after the last administration of saracatinib +/- paclitaxel (as per 5.3.3). Inability or unwillingness to give informed consent. Ongoing active infection or a documented history of HIV infection, Hepatitis B or C. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease (see Appendix 8). Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease. Use of immunosuppressive therapy taken within 4 weeks of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question is to see whether adding the drug saracatinib to weekly paclitaxel chemotherapy improves 6 month progression-free survival* in patients with platinum-resistant ovarian cancer. *The length of time during and after treatment in which a patient is living with a disease that does not get worse. This trial is focusing on the number of patients who achieve a progression-free survival of at least 6 months. ;Secondary Objective: The secondary research questions are to investigate the safety and tolerability of treating patients with saracatinib and weekly paclitaxel, to measure the overall survival rate of patients at 2 years post treatment, to measure the progression free survival and time to progression, to measure the response rate and duration of response, and to look at the health economics and quality of life implications of treating patients with this regimen.;Primary end point(s): 6 month progression free survival (PFS) rate based on combined RECIST v1.1/GCIG CA125 criteria. | — |
Countries
United Kingdom
Outcome results
None listed