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

This study has been terminated.
(Slow Accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00583622
First received: December 20, 2007
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: Bevacizumab
Drug: Carboplatin
Drug: Docetaxel
Drug: Gemcitabine
Drug: Melphalan
Procedure: Stem Cell Transplant
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 [ Time Frame: Up to 6 Months ] [ Designated as safety issue: No ]
    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:
  • Participant Response [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: December 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583622

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00583622     History of Changes
Other Study ID Numbers: 2007-0368
Study First Received: December 20, 2007
Results First Received: February 26, 2013
Last Updated: April 10, 2013
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Antibodies, Monoclonal
Melphalan
Gemcitabine
Docetaxel
Bevacizumab
Carboplatin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Myeloablative Agonists
Immunosuppressive Agents
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on July 29, 2014