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Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, December 2007

Sponsors and Collaborators: Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Eli Lilly and Company
Sanofi-Synthelabo
Genentech
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00418093
  Purpose

The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with recurrent mullerian carcinoma. We will also collect more information about the safety and side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Bevacizumab
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    Bevacizumab    Oxaliplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Estimate the progression free survival and time to tumor progression, response rate, and duration of response following treatment with oxaliplatin, gemcitabine and bevacizumab in this patient population. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the nature and degree of toxicities following treatment with oxaliplatin, gemcitabine, and bevacizumab in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   40
Study Start Date:   September 2006
Estimated Study Completion Date:   September 2008
Estimated Primary Completion Date:   September 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Gemcitabine
    Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
    Drug: Oxaliplatin
    Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
    Drug: Bevacizumab
    Given intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
Detailed Description:
  • The study treatment is divided into periods called cycles. Each cycle is 28 days long. Participants will be given the study drugs intravenously on day 1 and day 15 of each cycle.
  • Gemcitabine will be given first, over a period of 30 minutes. Then oxaliplatin over a period of 2 hours. Finally, bevacizumab will be given over a period of 30 to 90 minutes. Participants will continue study treatment as long as their tumor is not growing and they are not experiencing unacceptable side effects. If the tumor goes away completely, the participant will have 2 more cycle of study treatment.
  • Blood will be drawn for routine testing every week during study treatment to check for side effects. Before day 1 and 15 of each cycle the following tests and procedures will be performed: a medical history; complete physical exam; vital signs; blood tests; and urine tests. Before day 1 of every other cycle, the following additional procedures will be performed: A CT scan, x-ray or ultrasound of your abdomen and pelvis; an x-ray of the chest (if required by the study doctor); blood tests; and urine samples.
  • If the participant's tumor goes away, they will be asked to return to the clinic for follow-up visits every 3 months for 2 years, then every 6 months for 3 years. At each follow-up visit the following tests and procedures will be performed: medical history; complete physical examination; CT scan, x-ray or ultrasound of the abdomen and pelvis; x-ray of the chest; and other tests if the doctor feels they are needed.
  • There is an optional sub-study that six subjects will be asked to take a part in that will give the study doctors important information about the way the body uses and breaks down the study drugs. This sub-study will involve special surgical procedures and scans that will be done during cycle 1 of the study treatment.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic or cytologic confirmation of the original primary tumor is required.
  • Must have measurable disease which is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be >20mm when measured by conventional techniques.
  • Must have at least one "target lesion" to be used to assess response.
  • Platinum-sensitive tumors, defined as a platinum free interval of at least 6 months, and may have had up to two prior treatment regimens.
  • ECOG score of 0 or 1
  • Life expectancy of 12 weeks or longer
  • 18 years of age or older
  • Adequate bone marrow, renal, neurologic and liver function
  • Normal blood coagulation parameters

Exclusion Criteria:

  • Chemotherapy within last 3 weeks
  • Current, recent (within 4 weeks), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
  • Known bleeding disorder or coagulopathy, or history of stroke.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry or the anticipation of need for major surgical procedure during the course of the study.
  • Minor surgical procedures within 14 days of study entry.
  • Significant cardiovascular disease, NYHA Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, a history of DVT, or Grade II or greater, clinically significant peripheral vascular disease within 1 year of study entry.
  • Urine protein:creatinine ration greater than or equal to 1.0
  • History or clinical evidence of CNS disease
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who have evidence of disease within last three years.
  • More than 2 prior lines of chemotherapy
  • Previous treatment with a VEGF targeted inhibitor or antibody
  • Serious non-healing wound, ulcer or bone fracture
  • Prior radiation therapy to more than one-third of hematopoietic sites.
  • History of abdominal fistulas, gastrointestinal perforation, intra-abdominal abscess, or partial bowel obstruction within 6 months
  • Pregnant or lactating
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418093

Contacts
Contact: Neil Horowitz, MD     617-724-4800     nhorowitz@partners.org    
Contact: Anthony Luzzi     617-726-1634     aluzzi@partners.org    

Locations
United States, Massachusetts
Massachusetts General Hospital     Recruiting
      Boston, Massachusetts, United States, 02114
      Principal Investigator: Neil Horowitz, MD            
Dana-Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Principal Investigator: Ursula Matulonis, MD            

Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Eli Lilly and Company
Sanofi-Synthelabo
Genentech

Investigators
Principal Investigator:     Neil Horowitz, MD     Massachusetts General Hospital    
  More Information


Responsible Party:   Dana-Farber Cancer Institute ( Neil Horowitz, MD )
Study ID Numbers:   04-356
First Received:   January 2, 2007
Last Updated:   December 19, 2007
ClinicalTrials.gov Identifier:   NCT00418093
Health Authority:   United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
mullerian carcinoma  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Bevacizumab
Ovarian Diseases
Fallopian Tube Neoplasms
Recurrence
Carcinoma
Fallopian Tube Diseases
Genital Diseases, Female
Oxaliplatin
Endocrinopathy
Fallopian tube cancer
Gemcitabine
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on September 23, 2008




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