Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma
Condition: Primary Peritoneal Carcinoma; Ovarian Carcinoma; Fallopian Tube Carcinoma
MeSH terms: Carcinoma
Intervention: neoadjuvant chemotherapy
Intervention description: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: peritoneal; carcinoma; ovarian; fallopian tube; neoadjuvant chemotherapy; surgical debulking

Summary:

      This is a prospective study to evaluate the hypothesis that platinum-based neoadjuvant
      chemotherapy followed by interval surgical debulking with platinum-based adjuvant
      chemotherapy is associated with improved maximal surgical cytoreduction rates, comparable
      survival, decreased morbidity, and increased quality of life in patients with International
      Federation of Gynecologic Oncology stages IIIC and IV ovarian, primary peritoneal, or
      fallopian tube cancer when compared to historical controls and to evaluate the hypothesis
      that cancer induced inflammation is a predictor of poor prognosis and response to therapy in
      this group of ovarian cancer patients.
    

Eligibility criteria:

        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.