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Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583622
Recruitment Status : Terminated (Slow Accrual)
First Posted : December 31, 2007
Results First Posted : May 21, 2013
Last Update Posted : May 21, 2013
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if bevacizumab, when given in combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan, cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin), can help to control ovarian cancer during a stem cell transplant. The safety of this drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Bevacizumab Drug: Carboplatin Drug: Docetaxel Drug: Gemcitabine Drug: Melphalan Procedure: Stem Cell Transplant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab Combined With High-Dose Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Patients With Advanced Epithelial Ovarian Cancer
Study Start Date : December 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Bevacizumab + High-Dose Chemotherapy
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
Drug: Bevacizumab
5 mg/kg by vein daily over 90 minutes for 2 Days
Other Names:
  • Avastin™
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Drug: Carboplatin
333 mg/m^2 by vein over 2 hours for 3 Days
Other Name: Paraplatin®

Drug: Docetaxel
300 mg/m^2 by vein over 2 hours for 1 Day
Other Name: Taxotere

Drug: Gemcitabine
1,800 mg/m2 by vein over 3 hours for 4 Days
Other Names:
  • Gemzar®
  • Gemcitabine Hyrdrochloride

Drug: Melphalan
50 mg/m^2 by vein over 15 minutes for 3 Days

Procedure: Stem Cell Transplant
  • Stem Cell Removal via apheresis through a central venous catheter (CVC), usually in chest
  • Stem Cell Replacement through CVC over about 30-60 minutes, Day 7 of treatment, following study drug regimen
Other Name: SCT

Primary Outcome Measures :
  1. Event-Free (EF) Rate [ Time Frame: Up to 6 Months ]
    Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.

Secondary Outcome Measures :
  1. Participant Response [ Time Frame: Up to 6 months ]
    Number of participants evaluated using Response to Treatment in Solid Tumors (RECIST) with definitions of Complete Response (CR): disappearance of all target lesions; and, Partial Response: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Maintained Continued CR: participants who entered study in a CR and maintained CR post study treatment. Evaluations once a week till Day +30, then Days 30, 60, and 100 then at 6 months or until disease progression.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 - <70.
  2. Patients with advanced ovarian, fallopian or primary peritoneal cancer in second or later complete remission, or untreated or refractory relapse, defined as relapse within 6 months of prior platinum treatment or lack of response to salvage treatment.
  3. No evidence of small bowel obstruction, as determined by CT scan of the abdomen and pelvis with oral and rectal contrast, within 30 days before the initiation of study treatment.
  4. Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >=60 ml/min, and urinary protein excretion <=500 mg/day.
  5. Adequate hepatic function, as defined by serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <=3 * upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <=2 * ULN or considered not clinically significant.
  6. Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >=50% of predicted, corrected for volume or hemoglobin.
  7. Adequate cardiac function with left ventricular ejection fraction >=45%. No uncontrolled arrhythmias or symptomatic cardiac disease.
  8. Zubrod performance status <2.

Exclusion Criteria:

  1. Failure to collect more than 3 * 10e6 CD34+ stem cells/kg body weight
  2. Patients with unresolved grade 3 or greater non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the principal investigator.
  3. Major surgery within 30 days before the initiation of study treatment
  4. Radiotherapy within 21 days prior to initiation of study treatment
  5. Patients with active Central Nervous System (CNS) disease.
  6. Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Principal Investigator and consider liver biopsy.
  7. Uncontrolled infection, including HIV or HTLV-1 infection.
  8. Aspirin (> 325 mg/day) use within 10 days before initiation of study treatment.
  9. Ongoing uncontrolled hypertension (>140/90 mm Hg on medication).
  10. Non-healing wound or significant traumatic injury within 30 days before the initiation of study treatment
  11. Previous autologous or allogeneic stem cell transplant during the past year.
  12. Positive Beta HCG test in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583622

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United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Yago Nieto, MD, PhD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00583622    
Other Study ID Numbers: 2007-0368
First Posted: December 31, 2007    Key Record Dates
Results First Posted: May 21, 2013
Last Update Posted: May 21, 2013
Last Verified: April 2013
Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
Epithelial Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action