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A Phase II Randomized Study: Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


Phase 2
21 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tubes Cancer, Peritoneal Cancer

Thank you

Trial Information

A Phase II Randomized Study: Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


Inclusion Criteria:



- Age > 21 years old.

- Patients with histologic diagnosis of epithelial ovarian carcinoma, primary
peritoneal carcinoma, or fallopian tube carcinoma that has recurred >6 months since
platinum-based chemotherapy (first recurrence) and who are scheduled for secondary
surgical evaluation/cytoreduction.

- Histologic epithelial cell types include serous, endometrioid, clear cell, or
undifferentiated carcinomas, transitional cell carcinoma, mixed epithelial carcinoma,
malignant Brenner's tumor, or adenocarcinoma N.O.S.

- Karnofsky Performance Status (KPS) of ≥ 70%.

- Disease-free interval < 30 months.

- No prior chemotherapy in the recurrent setting. Prior hormonal therapy is permitted.
Concomitant anti-neoplastic anti-hormonal therapy (including tamoxifen, aromatase
inhibitors etc.) is not allowed for patients participating in study treatment.
Low-dose (physiologic) estrogen hormone-replacement therapy (HRT) may be given.

- Patients receiving maintenance biologic therapy are eligible, provided their
recurrence is documented more than 6 months from completion of primary cytotoxic
chemotherapy (includes maintenance chemotherapy) and a minimum of 3 weeks has elapsed
since their last infusion of biologic therapy at the start of protocol intervention,
day 1.

- Patients will be consented prior to the surgical evaluation/cytoreductive surgery.

- Patients must have less than or equal to 0.5 cm residual disease at the completion of
the secondary surgery to be eligible for the study.

- Patients must be, after evaluation by the investigator, appropriate candidates for
the administration of 5 to 6 cycles of standard platinum-based combination
chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, or
carboplatin and gemcitabine) following CRS with or without HIPEC.

- Bone marrow function:

- Hemoglobin ≥ 8.5 g/dL.

- Absolute neutrophil count (ANC) ≥ 1,000/mm3.

- Platelets ≥ 100,000/mm3.

- Renal function:

- Creatinine ≤ 1.5 times the upper limit of normal (ULN) or calculated creatinine
clearance ≥ 60ml/min.

- Hepatic function:

- Bilirubin ≤ 1.5 times ULN.

- ALT ≤ 3 times the ULN.

- AST ≤ 3 times the ULN.

- Neurologic function:

Peripheral neuropathy ≤ CTC AE grade 2.

- Blood coagulation parameters:

- PT with an INR of ≤ 1.5 and a PTT ≤ 1.5 times the ULN. For patients on full-dose
warfarin, in-range INR (usually between 2 and 3) and a PTT <1.2 times the ULN.

- Patients of childbearing potential must have a negative serum pregnancy test within 2
weeks prior to CRS and must be practicing an effective form of contraception during
the study period.

Exclusion Criteria:

- Tumors of low malignant potential (borderline carcinomas).

- Subjects who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded.

- Patients with a history of primary endometrial cancer are excluded unless the
following conditions are met:

- Stage not greater than IA.

- Not a poorly differentiated subtype (including papillary serous, clear cell or other
FIGO grade 3 lesions)

- With the exception of non-melanoma skin cancer and other specific malignancies as
noted above, subjects with other invasive malignancies, who had any evidence of the
other cancer present within the last 3 years or whose previous cancer treatment
contraindicates this protocol therapy, are excluded.

- Subjects with known active acute hepatitis.

- Subjects with active infection that requires parenteral antibiotics.

- Active coronary artery disease (defined as unstable angina or a positive cardiac
stress test).

- Patients with a history of coronary artery disease may be included if they have had a
normal stress test within 30 days of enrollment.

- Uncontrolled hypertension defined as > 140/90 and not cleared for surgery at the time
of consent..

- New York Heart Association (NYHA) Class II or higher Congestive heart failure.

- Renal insufficiency with serum creatinine level ≥ 1.5 times the upper limit of normal
or calculated creatinine clearance < 60 ml/min.

- History of cerebrovascular disease.

- Immune deficiency.

- Patients with other concurrent severe medical problems unrelated to the malignancy
that would significantly limit full compliance with the study or places them at an
unacceptable risk for participation in the study.

- Patients under the age of 21. This protocol does not include children because the
number of children with these types of cancer is limited, and because the majority is
already part of a nationwide pediatric cancer research network.

- Patients with known carboplatin or cisplatin allergy.

- Evidence of extensive intraperitoneal adhesions at the time of surgery, as determined
by the operating surgeon which prohibits intraperitoneal therapy.

- Life expectancy < 12 weeks.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determine the proportion of patients who are without evidence of disease progression

Outcome Description:

A proportion of patients > 40%, who are without evidence of disease progression at 24 months, is considered acceptable, whereas a proportion of < 25% is considered not acceptable in this patient population.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Dennis Chi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-275

NCT ID:

NCT01767675

Start Date:

January 2013

Completion Date:

January 2018

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tubes Cancer
  • Peritoneal Cancer
  • Secondary Cytoreductive Surgery
  • Carboplatin
  • Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
  • 12-175
  • Fever
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville Centre, New York  11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York