Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

NCT00418093 | Terminated Phase 2 Results

• 1 other identifier: 04-356
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

mullerian carcinoma

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Progression Free Survival

  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

• Overall Survival

  Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months

• Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.

  Toxicities were assessed every cycle and for up to 30 days after being removed from the trial

Study Arms (1)

Chemotherapy

EXPERIMENTAL

All patients received oxaliplatin, gemcitabine, and bevacizumab

Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Bevacizumab

Interventions

Gemcitabine DRUG

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.

Chemotherapy

Oxaliplatin DRUG

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.

Chemotherapy

Bevacizumab DRUG

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.

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Adequate bone marrow, renal, neurologic and liver function
• Normal blood coagulation parameters

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: collaborator
• Eli Lilly and Company: collaborator
• Sanofi-Synthelabo: collaborator
• Genentech, Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Gemcitabine; Oxaliplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The trial was closed after enrolling 19 of the 53 projected patient accrual.

Results Point of Contact

• Title: Neil Horowitz, MD
• Organization: Dana-Farber Cancer Institute

nhorowitz@partners.org

617-732-8843

Study Officials

• Neil Horowitz, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic Oncologist

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: September 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 19, 2014
• Results First Posted: June 19, 2014

Record last verified: 2014-06

Locations

US (2)