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New treatment option for Fallopian Tube Endometrioid Adenocarcinoma
Official title Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer
ClinicalTrials.gov ID: NCT05415709
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for fallopian tube endometrioid adenocarcinoma.
Also referred to as Blastocarb, Carboplat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand (English-speaking), and willingness to sign a written, informed consent
- Age \> 18 years old
- Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by:
- Biopsy/histology (either by treatment radiology or laparoscopy) OR
- Cytology; If diagnosis is based on cytology the following criteria must be met:
You likely can't join if
- History of breast cancer or previous malignancy within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous...
- Low grade serious carcinoma of the ovary or borderline ovarian tumors
- History or current diagnosis of inflammatory bowel disease
- History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery and be replaced
See the full eligibility criteria
- Ability to understand (English-speaking), and willingness to sign a written, informed consent
- Age \> 18 years old
- Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by:
- Biopsy/histology (either by treatment radiology or laparoscopy) OR
- Cytology; If diagnosis is based on cytology the following criteria must be met:
- Immunohistochemistry on the block from cytology to demonstrate Mullerian origin
- Presence of pelvic mass AND CA 125 \> 200kU/I AND CA125/CEA ratio \> 25 at initial diagnosis
- Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (diagnosed by computed tomography [CT]/magnetic resonance imaging [MRI], ultrasound, or...
- Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon
- Patient must be planned or scheduled to undergo interval cytoreductive surgery after cycle 3-4 of neoadjuvant surgery
- Completion of three cycles of neoadjuvant chemotherapy (NACT) with standard therapy (carboplatin [area under the curve (AUC) 5-6] day [D]1 + paclitaxel [175 mg/m\^2] D1 every 3 weeks)
- Following 3-4 cycles of NACT partial or complete response
- Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3/prior to surgery
- Fit for major surgery, American Society of Anesthesiologists (ASA )1 or ASA 2
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2
- Serum creatinine \< 1.4 mg/dL
- Creatinine clearance \> 60 ml/min (Cockcroft-Gault formula)
- White blood cell count \> 3.5 x 10\^9 cells/L
- Absolute neutrophil count \> 1.5 kg/ul
- Platelets \> 100,000/ul
- Total bilirubin within 1.5 x normal institutional limits
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal
- For quality of life assessment, baseline questionnaires should be filled in before randomization
- History of breast cancer or previous malignancy within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Low grade serious carcinoma of the ovary or borderline ovarian tumors
- History or current diagnosis of inflammatory bowel disease
- History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery and be replaced
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.