NCT00653328

Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma

A Phase II Study of Atrasentan (ABT-627) Plus DOXIL in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Serous Papillary Adenocarcinoma Following Platinum + Taxane Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors may be in combination with chemotherapy. The optimal use of atrasentan may be in combination with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer, and peritoneal serous papillary adenocarcinoma. Due to its manageable toxicity profile, ease of administration, and activity in both platinum sensitive as well as platinum-resistant patients, Doxil has become the 2nd-line treatment of choice for women with advanced stage ovarian cancer that has progressed following 1st-line platinum/taxane therapy. PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.

Detailed description

OBJECTIVES: Primary * To determine the median time to tumor progression in patients with recurrent ovarian epithelial cancer, fallopian tube adenocarcinoma, or peritoneal serous papillary adenocarcinoma treated with Doxil and atrasentan hydrochloride. Secondary * To determine the objective response rate and survival of patients treated with this regimen. * To determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with platinum-taxane (sensitive vs resistant). Patients will be administered Doxil 50 mg/m2 intravenous every 28 days and take atrasentan 10 mg orally everyday continuously beginning on Day 1. Patients will continue Doxil + atrasentan in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days and every 2 months thereafter.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	atrasentan hydrochloride	Atrasentan 10 mg orally everyday continuously beginning on Day 1.
DRUG	doxil	50 mg/m2 intravenously every 28 days

Timeline

• Start date: 2003-05-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-04-04
• Last updated: 2012-05-23
• Results posted: 2011-04-21

Locations

6 sites across 1 country: United States