Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Dana-Farber Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
First received: January 2, 2007
Last updated: May 12, 2011
Last verified: May 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

Resource links provided by NLM:


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: December 2011
Estimated Primary Completion Date: June 2011 (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

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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 Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Neil Horowitz, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00418093     History of Changes
Other Study ID Numbers: 04-356
Study First Received: January 2, 2007
Last Updated: May 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
mullerian carcinoma

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Gemcitabine
Oxaliplatin
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014