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



Status:Recruiting
Conditions:Ovarian Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:21 - Any
Updated:3/10/2019
Start Date:January 8, 2013
End Date:January 2020
Contact:Oliver Zivanovic, MD
Phone:212-639-7033

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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

The purpose of this study is to see if the investigators can improve the treatment of this
type of cancer. They want to find out what effects, good and/or bad, giving heated
chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has
on the patient and this type of cancer.

The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of
chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to
get into and kill the cancer cells. The drug used for HIPEC will be carboplatin, a Food and
Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary
peritoneal cancer.


Inclusion Criteria:

Inclusion Criteria for Eligibility Prior to Surgery:

- 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 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 ≤ 1.5mg/dl

- 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 oral
anti-coagulation (such as warfarin or rivaroxaban), 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.

Inclusion Criteria for Eligibility Post-Surgery:

- Patients will be consented prior to the surgical evaluation/cytoreductive surgery.
Patients must have less than or equal to 0.5cm residual disease at the completion of
the secondary surgery to be eligible for the study.

Exclusion Criteria:

Exclusion Criteria for Eligibility Prior to Surgery:

- 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 1 year 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.

- History of cerebrovascular disease.

- Immune deficiency: Clinically significant primary or acquired immune deficiency (i.e.
AIDS or on immunosuppressive medication after organ transplant).

- 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 with known carboplatin or cisplatin allergy.

- Life expectancy < 12 weeks.

Exclusion Criteria for Eligibility Post-Surgery:

- Evidence of extensive intraperitoneal adhesions at the time of surgery, as determined
by the operating surgeon which prohibits intraperitoneal therapy.
We found this trial at
12
sites
Rochester, Minnesota 55905
Principal Investigator: Carrie L. Langstraat, MD
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-7033
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Phone: 773-702-8222
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Commack, New York 11725
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500 Westchester Avenue
Harrison, New York 10604
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Hartford, Connecticut 06102
Phone: 860-972-1284
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Miami, Florida 33183
Phone: 305-666-1811
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Middletown, New Jersey 07748
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-7033
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Oliver Zivanovic, MD
Phone: 212-639-7033
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Rockville Centre, New York 11570
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