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Neoadjuvant Platinum-based Chemotherapy in Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma Trial Protocol


N/A
18 Years
N/A
Open (Enrolling)
Both
Primary Peritoneal Carcinoma, Ovarian Carcinoma, Fallopian Tube Carcinoma

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Trial Information

Neoadjuvant Platinum-based Chemotherapy in Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma Trial Protocol


Inclusion Criteria:



- Patients with biopsy proven stage IIIC/IV epithelial ovarian cancer, primary
peritoneal, fallopian tube carcinoma. If a core biopsy is not possible, fine-needle
aspirate showing adenocarcinoma is acceptable in the setting of a pelvic mass and
presence of metastasis outside the pelvis measuring at least 2 cm, regional
lymph-node metastasis or proof of stage IV disease, and ratio of CA 125 to CEA
greater than 25. If CA 125 to CEA ratio is 25 or lower, barium enema, gastroscopy,
and mammography must be negative.

- Patients must have adequate:

- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to
1,500/μl, equivalent to Common Toxicity Criteria for Adverse Events v3.0(CTCAE)
Grade 1. This ANC cannot have been induced or supported by granulocyte colony
stimulating factors.

- Platelets greater than or equal to 100,000/μl, CTCAE Grade 0-1. Renal function:
Creatinine ≤1.5 x institutional upper limit of normal ULN), CTCAE Grade 1.

- Hepatic function: Bilirubin ≤ 1.5 x ULN, CTCAE Grade 1.SGOT and alkaline
phosphatase ≤ 2.5 x ULN, CTCAE Grade 1.

- Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE
Grade 1.

- Blood coagulation parameters: 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 for management of venous thrombosis) and a
PTT <1.2 x ULN.

- Patients must have a World Health Organization Performance Status ≤2.

- Patients must be a candidate for surgery.

- An approved informed consent must be signed by the patient.

Exclusion Criteria:

- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded. Prior radiation for localized cancer of the breast, head and
neck, or skin is permitted, provided that it was completed more than three years
prior to registration, and the patient remains free of recurrent or metastatic
disease.

- Patients who have received prior chemotherapy for any abdominal or pelvic tumor are
excluded. Patients may have received prior adjuvant chemotherapy for localized breast
cancer, provided that it was completed more than three years prior to registration,
and that the patient remains free of recurrent or metastatic disease.

- Patients with a known synchronous primary endometrial cancer, or a past history of
primary endometrial cancer, are excluded, unless all of the following conditions are
met: Stage not greater than IA, no more than superficial myometrial invasion, without
vascular or lymphatic invasion, no poorly differentiated subtypes (including
papillary serous, clear cell or other FIGO Grade 3 lesions).

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

- Patients with acute hepatitis or active infection that requires parenteral
antibiotics are excluded.

- Patients with World Health Organization Performance Status of 3 or 4.

- Patients who are pregnant or nursing.

- Patients under the age of 18.

- Patients with a pelvic mass of any size that is causing pain, or other subjective
symptoms that are intolerable to the patient.

- Patients who are not candidates for interval surgical debulking secondary to
significant medical comorbidities.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients that achieve maximal surgical debulking

Outcome Description:

Percentage of patients that achieve maximal surgical debulking as defined by no gross residual disease following a Simon's 2-stage design.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Rachel Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lucille P. Markey Cancer Center at University of Kentucky

Authority:

United States: Institutional Review Board

Study ID:

11-GYN-098-MCC

NCT ID:

NCT01519869

Start Date:

March 2012

Completion Date:

February 2016

Related Keywords:

  • Primary Peritoneal Carcinoma
  • Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • peritoneal
  • carcinoma
  • ovarian
  • fallopian tube
  • neoadjuvant chemotherapy
  • surgical debulking
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Fallopian Tube Neoplasms

Name

Location

University of Kentucky Markey Cancer CenterLexington, Kentucky  40536