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TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00296816
  Purpose

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).


Condition Intervention Phase
Ovarian Cancer
Drug: oxaliplatin
Drug: docetaxel
Drug: bevacizumab.
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Docetaxel Bevacizumab Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: A Pilot Phase II Study Evaluating the Combination of Oxaliplatin and Docetaxel With Bevacizumab as First Line Therapy in Patients With FIGO Stage IB-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To evaluate efficacy of Docetaxel/Oxaliplatin/Avastin combination assessed as 1 year progression-free survival in patients with stage (FIGO) IB-IV ovarian, primary peritoneal or fallopian tube carcinoma [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess safety of oxaliplatin, docetaxel & bevacizumab combo therapy & tumor response rate, progression-free survival, recurrence-free survival,overall survival in patients with stage (FIGO) IB-IV ovarian, primary peritoneal, or fallopian tube carcinoma. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 145
Study Start Date: March 2006
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: oxaliplatin
    Oxaliplatin 85 mg/m2 IV Day 1 over 2 hours
    Drug: docetaxel
    Docetaxel 75 mg/m2 IV Day 1 over 1 hour
    Drug: bevacizumab.
    Bevacizumab 15 mg/kg IV Day 1 over 30-90 minutes
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Females18 years of age or older
  2. Patients 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. Patients 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. Patient must have adequate bone marrow function
  5. Patient must have adequate renal function
  6. Patient must have adequate urine protein/creatinine reaction (UPC) of <1.0;
  7. Patient 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 patient is on stable dose of therapeutic Warfarin or low molecular weight heparin) and a PTT < 1.2 times the upper limit normal.
  10. Patients 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. Patients with measurable and or evaluable disease are eligible. Patients may or may not have cancer-related symptoms.
  12. Patients 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. Patients with a GOG Performance Status of 0, 1, or 2 (See Appendix 1).

EXCLUSION CRITERIA:

  1. Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible. Patients 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. Patients 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 patient remains free of recurrent or metastatic disease.
  4. Patients who have received any prior anticancer chemotherapy or biologic therapy for any malignancy are excluded.
  5. Patients 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. Patients 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. Patient with acute hepatitis or active infection that requires parenteral antibiotics.
  8. Patients with serious, non-healing wound, ulcer, or bone fracture. This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.

    Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.

  9. Patients with active bleeding or pathologic conditions that carry high risk of bleeding,such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
  10. Patients 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. Patients with clinically significant cardiovascular disease.
  12. Patients with clinically significant proteinuria. Urine protein should be screened by urinalysis. Patients 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. Patients with or with anticipation of invasive procedures.
  14. Patients with GOG Performance Grade of 3 or 4.
  15. Patients who are pregnant or nursing.
  16. Patients 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. Patients 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 patient safety or the study drug evaluation for efficacy and safety.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296816

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Yasir Nagarwala, M.D. Sanofi-Aventis
  More Information

Responsible Party: sanofi-aventis ( Study Director )
Study ID Numbers: PM_L_0239
Study First Received: February 23, 2006
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00296816  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Bevacizumab
Ovarian Diseases
Carcinoma
Genital Diseases, Female
Docetaxel
Oxaliplatin
Fallopian tube cancer
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009