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A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)


Phase 2
18 Years
75 Years
Open (Enrolling)
Female
Bulky Stage IIIC and IV Epithelial Ovarian Cancer,, Fallopian Tube Cancer,, Primary Peritoneal Carcinoma

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Trial Information

A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)


This exploratory trial is to compare the efficacy of sequential chemotherapy,
intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous
chemotherapy alone in the first-line therapy for ovarian cancer.


Inclusion Criteria:



- Age ≥18 years to ≤ 75 years.

- Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph
node metastasis alone

- Optimal cytoreductive surgery, including hysterectomy, bilateral
salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a
residual disease no more than 1cm

- Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more
than postoperative 14 days for those with bowel resection.

- ECOG performance 0-2.

- No more than 3 cycles of chemotherapy prior to surgery.

- Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil
count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic:
bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin < 2.0, SGPT
less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance
greater than 40 mL/min.

- Comply with intraperitoneal chemotherapy and follow-up.

- Written informed consent.

Exclusion Criteria:

- Low-malignant potential ovarian tumor.

- Laboratory testing insufficiency. Hemoglobin < 10 g/dL. Renal insufficiency with
serum creatinine > 1.6.

- Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet
count less than 80,000/mm3.

- Active infection.

- Clinically significant gastrointestinal abnormalities.

- Active coronary artery disease, cerebrovascular disease, restrictive or obstructive
pulmonary disease, or congestive heart failure.

- Other condition that could interfere with provision of informed consent, compliance
to study procedures, or follow-up.

- Prior invasive malignancies within the last 5 years showing activity of disease.

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:

12-month disease non-progression rate

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Rongyu Zang, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Gynecologic Oncology Group

Authority:

China: Ethics Committee

Study ID:

V01-2009-03

NCT ID:

NCT01669226

Start Date:

April 2009

Completion Date:

December 2015

Related Keywords:

  • Bulky Stage IIIC and IV Epithelial Ovarian Cancer,
  • Fallopian Tube Cancer,
  • Primary Peritoneal Carcinoma
  • Ovarian Cancer
  • intraperitoneal chemotherapy
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

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