Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

This study has been terminated.
(THe study was terminated early due to a lack of accural)
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Eli Lilly and Company
Sanofi-Synthelabo
Genentech
Information provided by (Responsible Party):
Neil S. Horowitz, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00418093
First received: January 2, 2007
Last updated: June 18, 2014
Last verified: June 2014
  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: 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:
  • Partial Response Rate [ Time Frame: Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks) ] [ Designated as safety issue: No ]
    Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months ] [ Designated as safety issue: No ]
    Time participant remains free of progression of her disease. Evaluated by RECIST criteria

  • Overall Survival [ Time Frame: Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months ] [ Designated as safety issue: No ]
    Duration of time participants are alive after enrolling on the study. Assessed by clinical records

  • Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population. [ Time Frame: Toxicities were assessed every cycle and for up to 30 days after being removed from the trial ] [ Designated as safety issue: Yes ]
    The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported


Enrollment: 19
Study Start Date: September 2006
Study Completion Date: October 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy
All patients received oxaliplatin, gemcitabine, and bevacizumab
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.
  • Eastern Cooperative Oncology Group 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, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, a history of deep vein thrombosis, 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 central nervous system 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
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: 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 S. Horowitz, MD, Gynecologic Oncologist, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00418093     History of Changes
Other Study ID Numbers: 04-356
Study First Received: January 2, 2007
Results First Received: April 27, 2012
Last Updated: June 18, 2014
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 July 20, 2014