Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma
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.
Fallopian Tube Cancer
Peritoneal Cavity Cancer
Drug: atrasentan hydrochloride
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Median Time to Tumor Progression [ Time Frame: Date on study to the date of measured progressive disease, every 2 cycles (2 months) ] [ Designated as safety issue: No ]Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level >=2x baseline and >=70 IU/ml, confirmed by a second determination at least 28 days after the first determination
- Number of Patients With Objective Response [ Time Frame: At month 2 and monthly thereafter to cessation of treatment ] [ Designated as safety issue: No ]
Patient response to treatment:
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of >= 1 new lesions, and/or 2x CA-125 levels to >=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
- Overall Survival [ Time Frame: Date on study to date of death from any cause ] [ Designated as safety issue: No ]
- Number of Patients With Worst Grade Toxicities [ Time Frame: Weekly for 2 weeks, then monthly for 5 months ] [ Designated as safety issue: Yes ]Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria
|Study Start Date:||May 2003|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
|Experimental: Therapeutic Intervention||
Drug: atrasentan hydrochloride
Atrasentan 10 mg orally everyday continuously beginning on Day 1.
Other Names:Drug: doxil
50 mg/m2 intravenously every 28 days
Other Name: pegylated liposomal doxorubicin hydrochloride (Doxil)
- 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.
- 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.
|United States, Georgia|
|Central Georgia Hematology Oncology Associates, P.C.|
|Macon, Georgia, United States, 31201|
|United States, Kentucky|
|Kentuckiana Cancer Institute|
|Louisville, Kentucky, United States, 40202|
|United States, Tennessee|
|The Jones Clinic|
|Germantown, Tennessee, United States, 38138|
|Jackson-Madison County Hospital|
|Jackson, Tennessee, United States, 383013956|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|St. Thomas Health Services|
|Nashville, Tennessee, United States, 37205|
|Principal Investigator:||Marta Crispens, MD||Vanderbilt-Ingram Cancer Center|