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| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborators: |
Genentech University of New Mexico |
| Information provided by (Responsible Party): | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00846612 |
Purpose
This study is to study pharmacokinetics of Doxil using Doxil and Avastin on ovarian cancer patients who are resistant to or have relapsed from platinum-based therapy.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Drug: Doxil Drug: Bevacizumab (Avastin) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II and Pharmacokinetic Study of Avastin and Doxil in the Treatment of Platinum-resistant or Refractory Ovarian Cancer |
| Enrollment: | 15 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | July 2012 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Avastin-Doxil |
Drug: Doxil
1 cycle: 3 weeks; 30 mg/m^2, IV, every cycle
Other Name: pegylated doxorubicin liposome
Drug: Bevacizumab (Avastin)
1 cycle: every 3 weeks; 15 mg/kg, IV, beginning on cycle 2 and every cycle 20-24 hours following Doxil administration
Other Name: Avastin
|
This study registration at clinicaltrials.gov is divided into 2 records. This record (NCT00846612) is for pharmacokinetics of Doxil. Another record (NCT00945139) describes the efficacy and safety of the combination treatment.
Treatment upon diagnosis of epithelial ovarian cancer (EOC) consists of surgery to achieve maximal tumor debulking followed by platinum-based chemotherapy (carboplatin + paclitaxel). Recently, optimally (e.g., < 1 cm residual disease) debulked patients appear to benefit from regimens that include intraperitoneal administration of cisplatin. While complete response (CR) is frequently achieved, by two years 50% of the patients show signs of recurrence.
When EOC presenting at an advanced stage recurs, even after a CR had been achieved, it can no longer be totally eradicated. Nevertheless, a number of drugs lead to objective responses, patients benefit with a prolongation of survival. Anti-tumor activity of Doxil against ovarian cancer was noted in a phase I study, and this was followed by a phase II study that demonstrated activity in platinum and paclitaxel refractory disease. In the expanded phase II experience at the University of Southern California, responses to Doxil occurred preferably in disease that was not bulky and after fewer prior treatments. Typically, several cycles were required for maximum response, and some patients had prolonged stable disease. Subsequently, the study of Gordon et al established the preferred role of this drug formulation in the 2nd line-setting. It is logical, therefore, to build on this agent in trying to improve the outcome of patients with recurrent ovarian cancer, and in particular, to consider a combination with Avastin, since Avastin has shown agent activity in retrospective data and recent studies in EOC.
A combination of Doxil with Avastin has several aspects of interest to ovarian cancer treatment: 1) independent single-agent activity, 2) enhanced localization of Doxil is possible via increased half-life (if liposomal egress is diminished) and decreased tumoral interstitial pressure, 3) improved Doxil distribution, and 4) likely favorable toxicity profile since Doxil's only common problematic toxicity is to the skin (palmar-plantar erythrodysesthesia or PPE). Pharmacokinetic issues will be addressed in selected patients, by comparing cycle 1 (without Avastin) with cycle 2 (with Avastin).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Disease-Specific Exclusions:
General Medical Exclusions:
Avastin-Specific Exclusions:
Proteinuria at screening as demonstrated by either
Contacts and Locations| United States, New Mexico | |
| Univ. of New Mexico cancer research and treatment center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| NYU Cancer Center | |
| New York, New York, United States, 10016 | |
| NYU medical center (Tisch Hospital) | |
| New York, New York, United States, 10016 | |
| Bellevue Hospital | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Franco Muggia, MD | New York University School of Medicine |
More Information
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00846612 History of Changes |
| Other Study ID Numbers: | 06-948, Genentech AVF3910s |
| Study First Received: | February 18, 2009 |
| Last Updated: | November 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
refractory avastin doxil |
relapsed ovarian cancer platinum-resistant |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Doxorubicin Bevacizumab Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |