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Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, May 2009
First Received: December 20, 2007   Last Updated: May 21, 2009   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00583622
  Purpose

Primary Endpoint To derive estimates of the therapeutic impact produced by the new treatment, by analyzing the event-free survival (EFS).

Secondary Endpoints:

  1. To estimate the response rate (RR), and complete response (CR) rate and overall survival (OS) among patients with measurable disease
  2. To Describe the side effect profile of Bevacizumab/Gemcitabine/Docetaxel/Melphalan/Carboplatin (Bev/DMC) and

    Bevacizumab/Topotecan/Melphalan/Cyclophosphamide (Bev/TMC):

    • Extramedullary side effects
    • Engraftment rate.
  3. To derive estimates of the overall survival (OS)

Condition Intervention Phase
Ovarian Cancer
Drug: Bevacizumab
Drug: Carboplatin
Drug: Docetaxel
Drug: Gemcitabine
Drug: Melphalan
Procedure: Stem Cell Transplant
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Bevacizumab Combined With High-Dose Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Patients With Advanced Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Event-free (EF) rate, defined as the percent of patients free of relapse or disease progression at the end of 6 months. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bevacizumab + High-Dose Chemotherapy: Experimental
Bevacizumab + Carboplatin + Docetaxel + Gemcitabine + Melphalan
Drug: Bevacizumab
5 mg/kg By Vein Daily Over 90 Minutes x 2 Days
Drug: Carboplatin
333 mg/m^2 By Vein Over 2 Hours x 3 Days
Drug: Docetaxel
300 mg/m^2 By Vein Over 2 Hours x 1 Day
Drug: Gemcitabine
2,100 mg/m^2 By Vein Over 4 Hours x 4 Days
Drug: Melphalan
50 mg/m^2 By Vein Over 15 Minutes x 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 SGOT and SGPT <=3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <=2 x ULN or considered not clinically significant.
  6. Adequate pulmonary function with FEV1, FVC and 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 x 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 PI.
  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583622

Contacts
Contact: Yago Nieto, MD, PhD 713-792-8750

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Yago Nieto, MD, PhD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Yago Nieto, MD, PhD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Yago Nieto, MD, PhD/Associate Professor )
Study ID Numbers: 2007-0368
Study First Received: December 20, 2007
Last Updated: May 21, 2009
ClinicalTrials.gov Identifier: NCT00583622     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
Epithelial Ovarian Cancer
Bevacizumab
Carboplatin
Gemcitabine
Docetaxel
Melphalan

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Melphalan
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Bevacizumab
Docetaxel
Genital Diseases, Female
Antibodies, Monoclonal
Ovarian Cancer
Gemcitabine
Alkylating Agents
Endocrine Gland Neoplasms
Immunoglobulins
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Carboplatin
Ovarian Epithelial Cancer
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Antibodies
Radiation-Sensitizing Agents
Endocrinopathy
Antineoplastic Agents, Alkylating

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Melphalan
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Bevacizumab
Genital Diseases, Female
Docetaxel
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Gemcitabine
Alkylating Agents
Endocrine Gland Neoplasms
Ovarian Neoplasms
Growth Substances
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Carboplatin
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 10, 2009