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
Recruitment status was Active, not recruiting
Sponsor:
Dana-Farber Cancer Institute
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
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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:
Detailed Description:
-
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.
- 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 May 23, 2013