TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary

NCT00296816 | Completed Phase 2 Results

• 1 other identifier: PM_L_0239
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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®).

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Twelve-month Progression-free Survival (PFS) Rate in Participants

  Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: * appearance of a new lesion * symptomatic deterioration * progression of target or nontarget lesions * death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.

  up to 12 months following treatment initiation

Secondary Outcomes (8)

• Twenty Four-month Progression-free Survival (PFS) Rate in Participants

  up to 24 months following treatment initiation

• Median Time to Progression-free Survival (PFS)

  up to approximately 1300 days following treatment initiation

• Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)

  up to 12 months following treatment initiation

• Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline

  up to 12 months following treatment initiation

• Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline

  up to approximately 1500 days following treatment initiation

Study Arms (1)

Oxaliplatin/Docetaxel/Bevacizumab

EXPERIMENTAL

Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery

Drug: Bevacizumab (Avastin®); Drug: Docetaxel (Taxotere®); Drug: Oxaliplatin (Eloxatin®)

Interventions

Bevacizumab (Avastin®) DRUG

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

Oxaliplatin/Docetaxel/Bevacizumab

Docetaxel (Taxotere®) DRUG

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

Oxaliplatin/Docetaxel/Bevacizumab

Oxaliplatin (Eloxatin®) DRUG

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

Oxaliplatin/Docetaxel/Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females 18 years of age or older
• 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.
• 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.
• Participant must have adequate bone marrow function
• Participant must have adequate renal function
• Participant must have adequate urine protein/creatinine reaction (UPC) of \<1.0;
• Participant must have adequate neurologic function
• 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.
• 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.
• 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.
• Participants with measurable and non-measurable disease are eligible. Participants with suboptimal disease are eligible. Participants may or may not have cancer-related symptoms.
• 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.
• Participants with a GOG Performance Status of 0, 1, or 2.

You may not qualify if:

• 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.
• 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.
• 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.
• Participants who have received any prior anticancer chemotherapy or biologic therapy for any malignancy are excluded.
• 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.
• Participant with acute hepatitis or active infection that requires parenteral antibiotics.
• 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.
• Participants with active bleeding or pathologic conditions that carry high risk of bleeding,such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
• 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.
• Participants with clinically significant cardiovascular disease.
• 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.
• Participants with or with anticipation of invasive procedures.
• Participants with GOG Performance Grade of 3 or 4.
• Participants who are pregnant or nursing.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Docetaxel; Oxaliplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Limitations and Caveats

One site closed prematurely during the study. Every effort was made to collect, at minimum, any outstanding safety data for the participants at this site. As a result, participants from this site were included only in the safety analysis.

Results Point of Contact

• Title: Trial Trans[parency Team
• Organization: Sanofi

Contact_us@sanofi.com

Study Officials

• Phyllis Diener, BS, MT (ASCP)

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: March 1, 2006
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 23, 2012
• Results First Posted: August 23, 2012

Record last verified: 2011-08

Locations

US (1)