This pilot study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.
The name of the study intervention involved in this study is:
-implantable microdevice
Participants must have suspected or confirmed clinically advanced stage (III-IV, defined as disease outside of the pelvis) ovarian, fallopian tube, or peritoneal cancer. If a patient has suspected ovarian cancer but final histologic analysis does not show evidence of ovarian cancer, the patient will be removed from the study and replaced.
Cohort 1: Patients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.
Cohort 2: Patients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery.
Cohort 3: Patients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g. to confirm diagnosis of recurrent ovarian cancer and/or remove oligometastatic lesions.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the microdevice placement and the potential risk to the pregnancy of the biopsy/device placement in an abdominal lesion.
Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.
Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)
Single group
Microdevice
Combination productPlacement of 1 to 6 implantable microdevices with multiple miniature drug reservoirs into a tumor mass 24 +/- 8 hours prior to surgery. Drugs will be released over 24 (+/- 8) hours while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain. * Each microdevice will harbor up to 20 drugs and drug combinations relevant to the treatment of ovarian cancer. * Each drug or drug combination will be released from a single, separate reservoir. At least two reservoirs will harbor a drug vehicle only. * Drugs will include all or a subset of the following: Cisplatin, Carboplatin, Paclitaxel, Doxorubicin or pegylated liposomal doxorubicin (PLD), Cyclophosphamide, Etoposide, Gemcitabine, Ifosfamide, Pemetrexed, Topotecan, Vinorelbine, Olaparib, Niraparib, Rucaparib, Carboplatin + paclitaxel (combination), Carboplatin + doxorubicin (combination),Carboplatin + gemcitabine (combination)
Number of participants with adverse events as defined in the CTCAE v5.0
Descriptive statistics will be used to evaluate the safety of microdevice placement and removal, including reporting the maximum grade AE by type and organ class with 95% binomial confidence intervals.
Number of implanted microdevices successfully retrieved
Defined as the ability to retrieve the microdevice with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each microdevice considered to be relatively independent in terms of placement, retrieval, and analysis.
Measure local intratumor response to different agents
Response assessed via apoptotic index measured by immunohistochemistry. Inferences will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates.
Correlate extent of tumor response with platinum response category
Platinum response category is defined as follows for both initial and secondary platinum exposure: platinum refractory (progression within 2 months of platinum-based chemotherapy), platinum resistant (progression within 2-6 months of platinum-based chemotherapy), and platinum sensitive (progression within 6-12 months of platinum based chemotherapy). For dichotomous/categorical tumor features and patient outcomes, we will use Fisher's exact test. For continuous variables we will use a two-sided t-test if the data is approximately normally distributed, and Wilcoxon rank sum test if otherwise.
Correlate extent of tumor response with platinum-free interval
Platinum-free interval is defined as the interval between the date of the last platinum dose and the date of relapse detection. For dichotomous/categorical tumor features and patient outcomes, we will use Fisher's exact test. For continuous variables we will use a two-sided t-test if the data is approximately normally distributed, and Wilcoxon rank sum test if otherwise.
Correlate extent of tumor response with progression-free survival
Progression defined using RECIST 1.1 criteria; progression-free survival measured in months. For dichotomous/categorical tumor features and patient outcomes, we will use Fisher's exact test. For continuous variables we will use a two-sided t-test if the data is approximately normally distributed, and Wilcoxon rank sum test if otherwise.
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Brigham and Women's Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Dana-Farber Cancer Institute
Collaborator
