Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer

City of Hope

Status and phase

Active, not recruiting

Phase 1

Conditions

Stage IIIC Fallopian Tube Cancer AJCC v7

Stage IVB Uterine Corpus Cancer AJCC v7

Recurrent Fallopian Tube Carcinoma

Stage IIIA Uterine Corpus Cancer AJCC v7

Stage IIIA Ovarian Cancer AJCC v6 and v7

Stage IIIB Uterine Corpus Cancer AJCC v7

Stage IV Fallopian Tube Cancer AJCC v6 and v7

Stage IIIC Ovarian Cancer AJCC v6 and v7

Stage IIIC Primary Peritoneal Cancer AJCC v7

Stage IIIB Primary Peritoneal Cancer AJCC v7

Stage III Ovarian Cancer AJCC v6 and v7

Stage IV Primary Peritoneal Cancer AJCC v7

Stage IIIB Fallopian Tube Cancer AJCC v7

Stage IIIA Primary Peritoneal Cancer AJCC v7

Stage IV Uterine Corpus Cancer AJCC v7

Stage IIIA Fallopian Tube Cancer AJCC v7

Recurrent Primary Peritoneal Carcinoma

Stage III Fallopian Tube Cancer AJCC v7

Stage IIIC Uterine Corpus Cancer AJCC v7

Recurrent Ovarian Carcinoma

Recurrent Uterine Corpus Carcinoma

Stage IIIB Ovarian Cancer AJCC v6 and v7

Platinum-Resistant Ovarian Carcinoma

Stage IV Ovarian Cancer AJCC v6 and v7

FIGO Stage IVA Ovarian Cancer

Stage IVA Uterine Corpus Cancer AJCC v7

Stage III Primary Peritoneal Cancer AJCC v7

Stage III Uterine Corpus Cancer AJCC v7

FIGO Stage IVB Ovarian Cancer

Treatments

Other: Laboratory Biomarker Analysis

Drug: Gemcitabine Hydrochloride

Drug: Cisplatin

Procedure: Therapeutic Conventional Surgery

Other: Quality-of-Life Assessment

Drug: Carboplatin

Drug: Pegylated Liposomal Doxorubicin Hydrochloride

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01970722

116613

12316

122550

122035

NCI-2013-01948 (Registry Identifier)

108303

Details and patient eligibility

About

This phase I trial studies the side effects and how well surgery and heated chemotherapy with or without non-heated chemotherapy after surgery works in treating patients with ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.

Full description

PRIMARY OBJECTIVE:

I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.

SECONDARY OBJECTIVES:

I. To determine quality of life (QoL) and compare the outcomes to a historical control of IP chemotherapy (no HIPEC) for women with ovarian cancer.

II. To determine whether cytoreductive surgery with HIPEC alone is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.

III. To estimate progression-free survival (PFS). IV. To collect biospecimens and perform correlative translational studies focused on understanding the mechanisms of action of HIPEC on ovarian cancer.

OUTLINE:

Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (IP) over 60 minutes.

Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or intravenously (IV) at the discretion of the medical and gynecologic oncologists.

After completion of study treatment, patients are followed up at 3-6, 6-9, 9-12, and 12-15 months; every 3 months for 1 year; and then every 4 months for 1 year.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provided informed consent
Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery
Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky scale (KPS) >= 70%
Patients who are platinum-sensitive or platinum resistant
Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician
For patients with newly diagnosed-ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following:
- Decline in serum cancer antigen (CA) 125 level
- At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging
- Improvement of ascites volume
- Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery
- Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =< 1 and to baseline laboratory values as defined
Hemoglobin (HGB) >= 9 g/dL
White blood cell (WBC) >= 3,000/mcL
Absolute neutrophil count (ANC) >= 1,500/mcL
Platelets (PLT) >= 100,000/mcL
Total bilirubin within normal institutional limits
Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN)
Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockcroft-Gault formula
Neuropathy (sensory and motor) NCI CTCAE grade =< 2
Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control
Serum albumin >= 2.5
No active infection requiring antibiotics
Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer
Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter
Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia

Exclusion criteria

Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
Patients whose disease has progressed following at least 3 cycles of neoadjuvant chemotherapy as defined by at least one of the following:
- Doubling of serum CA-125 level
- At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions
- Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status)
Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
Patients whose circumstances do not permit completion of the study or the required follow-up
Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy
Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 1 year after completion of treatment)
Metastatic non-gynecologic or breast primaries
Sub-optimal resection as their surgical outcome
Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or urinary tract cancer

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Treatment (surgery, HIPEC cisplatin)

Experimental group

Description:

Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes. Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.

Treatment: