TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary
Condition: Ovarian Cancer
Intervention: Bevacizumab (Avastin®); Docetaxel (Taxotere®); Oxaliplatin (Eloxatin®)
Intervention description: 15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity; 75 mg/m^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity; 85 mg/m^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
Intervention MeSH terms: Bevacizumab; Docetaxel; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and
      oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of
      angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent
      addition of bevacizumab (Avastin®).
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. Females 18 years of age or older

          2. Participants with a histologic diagnosis of ovarian, primary peritoneal, or fallopian
             tube carcinoma, Stage Ib- IV, with either optimal (≤ 1 cm residual disease) or
             suboptimal residual disease ( > 1 cm maximal diameter any remaining lesion) following
             initial surgery.

          3. Participants with the following histologic epithelial cell types are eligible: Serious
             adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,undifferentiated
             carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell
             carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.

          4. Participant must have adequate bone marrow function

          5. Participant must have adequate renal function

          6. Participant must have adequate urine protein/creatinine reaction (UPC) of <1.0;

          7. Participant must have adequate neurologic function

          8. Hepatic function: Total Bilirubin ≤ ULN; AST and ALT and Alkaline Phosphatase must be
             within the range allowing for eligibility. In determining eligibility the more
             abnormal of the two values (AST or ALT) should be used.

          9. 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 participant is on stable dose
             of therapeutic Warfarin or low molecular weight heparin) and a PTT < 1.2 times the
             upper limit normal.

         10. Participants must be enrolled in the study prior to 50 days (every effort will be made
             for prior to 28 days) after initial surgery performed for the combined purpose of
             diagnosis, staging and cytoreduction.

         11. Participants with measurable and non-measurable disease are eligible. Participants
             with suboptimal disease are eligible. Participants may or may not have cancer-related
             symptoms.

         12. Participants who have met the pre-entry requirements specified including serologic
             measurement of CA-125 as a baseline for subsequent determination of response using
             Rustin criteria.

         13. Participants with a GOG Performance Status of 0, 1, or 2.

        EXCLUSION CRITERIA:

          1. Participants with a current diagnosis of epithelial ovarian tumor of low malignant
             potential (Borderline carcinomas) are not eligible. Participants with a prior
             diagnosis of a low malignant potential tumor that was surgically resected and who
             subsequently develop invasive adenocarcinoma are eligible, provided that they have not
             received prior chemotherapy for any ovarian tumor.

          2. Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or
             carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant
             potential tumors including so called micropapillary serous carcinomas are not
             eligible.

          3. Participants who have received prior radiotherapy to any portion of the abdominal
             cavity or pelvis are excluded. Prior radiation for localized cancer of the skin is
             permitted, provided that it was completed more than 5 years prior to enrollment, and
             the participant remains free of recurrent or metastatic disease.

          4. Participants who have received any prior anticancer chemotherapy or biologic therapy
             for any malignancy are excluded.

          5. Participants with 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 I-B; Less than 3 mm invasion without vascular or lymphatic
             invasion; No poorly differentiated subtypes, including papillary serous, clear cell,
             or other FIGO Grade 3 lesions.

          6. Participants with any history of cancer, with the exception of inclusion criteria #2
             and #3, and non-melanoma skin cancer, who are cancer free for the last 5 years, are
             excluded.

          7. Participant with acute hepatitis or active infection that requires parenteral
             antibiotics.

          8. Participants with serious, non-healing wound, ulcer, or bone fracture. This includes
             history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
             within 28 days.

             Participants with granulating incisions healing by secondary intention with no
             evidence of fascial dehiscence or infection are eligible but require weekly wound
             examinations.

          9. Participants with active bleeding or pathologic conditions that carry high risk of
             bleeding,such as known bleeding disorder, coagulopathy, or tumor involving major
             vessels.

         10. Participants with history or evidence upon physical examination of CNS disease,
             including primary brain tumor, seizures not controlled with standard medical therapy,
             any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient
             ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date
             of treatment on this study.

         11. Participants with clinically significant cardiovascular disease.

         12. Participants with clinically significant proteinuria. Urine protein should be screened
             by urinalysis. Participants discovered to have a urine protein: serum creatinine ratio
             greater than or equal to 1 should undergo a 24-hour urine collection, which must be an
             adequate collection and must demonstrate < 1000 mg protein/24 hr to allow
             participation in the study.

         13. Participants with or with anticipation of invasive procedures.

         14. Participants with GOG Performance Grade of 3 or 4.

         15. Participants who are pregnant or nursing.

         16. Participants with known hypersensitivity to Chinese hamster ovary cell products or
             other recombinant human or humanized antibodies and hypersensitivity to polysorbate 80
             or hypersensitivity to any of the study drugs and its ingredients.

         17. Participants who participated in a study with any investigational product/device
             within the last 30 days.

         18. Any medical condition that in the judgment of the investigator would jeopardize any
             participant safety or the study drug evaluation for efficacy and safety.