Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

Ovarian Cancer Clinical Trial

Official title:

A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00418093
• Other study ID #: 04-356
• Status: Terminated
• Phase: Phase 2
• First received: January 2, 2007
• Last updated: June 18, 2014
• Start date: September 2006
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Eli Lilly and Company, Genentech, Inc., Massachusetts General Hospital, Sanofi-Synthelabo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial Response Rate	Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria	Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)	No
Secondary	Progression Free Survival	Time participant remains free of progression of her disease. Evaluated by RECIST criteria	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	No
Secondary	Overall Survival	Duration of time participants are alive after enrolling on the study. Assessed by clinical records	Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months	No
Secondary	Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.	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	Toxicities were assessed every cycle and for up to 30 days after being removed from the trial	Yes