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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00436501 |
RATIONALE: VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving VEGF Trap together with docetaxel may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of VEGF Trap when given together with docetaxel and to see how well they work in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: aflibercept Drug: docetaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II and Pharmacokinetic Study of Plus VEGF Trap (AVE0005, NSC#724770) in Patients With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer |
Estimated Enrollment: | 52 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of VEGF Trap followed by a phase II study.
After the completion of study treatment, patients are followed at 1 and 2 months and then periodically thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
Must have received 1 prior platinum-based chemotherapy regimen (for primary disease) containing carboplatin, cisplatin, or other organoplatinum compound
Initial treatment may have included any of the following:
PATIENT CHARACTERISTICS:
No active bleeding or pathologic condition that would carry a high risk of bleeding, including any of the following:
No history or evidence of other CNS disease, including any of the following:
No clinically significant cardiovascular disease, including any of the following:
Able to undergo an MRI scan
PRIOR CONCURRENT THERAPY:
Recovered from prior therapy to NCI CTCAE v3.0 grade ≤ 1
Prior docetaxel for primary or recurrent disease allowed provided the following criteria are met:
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Principal Investigator: | Robert L. Coleman, MD | M.D. Anderson Cancer Center |
Principal Investigator: | Anil K. Sood, MD | M.D. Anderson Cancer Center |
Responsible Party: | M. D. Anderson Cancer Center at University of Texas ( Robert C. Bast, Jr ) |
Study ID Numbers: | CDR0000530016, MDA-2006-0329 |
Study First Received: | February 15, 2007 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00436501 History of Changes |
Health Authority: | Unspecified |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Fallopian Tube Cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Fallopian Tube Neoplasms |
Recurrence Fallopian Tube Diseases Docetaxel Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Pharmacologic Actions Fallopian Tube Neoplasms |
Fallopian Tube Diseases Adnexal Diseases Docetaxel Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |