Study Stopped
Abbott (drug manufacturer) discontinued manufacture of ABT-627
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
3 other identifiers
interventional
15
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2003
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
April 21, 2011
CompletedMay 23, 2012
May 1, 2012
5.8 years
April 3, 2008
September 30, 2010
May 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Time to Tumor Progression
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
Date on study to the date of measured progressive disease, every 2 cycles (2 months)
Secondary Outcomes (3)
Number of Patients With Objective Response
At month 2 and monthly thereafter to cessation of treatment
Overall Survival
Date on study to date of death from any cause
Number of Patients With Worst Grade Toxicities
Weekly for 2 weeks, then monthly for 5 months
Study Arms (1)
Therapeutic Intervention
EXPERIMENTALInterventions
Atrasentan 10 mg orally everyday continuously beginning on Day 1.
50 mg/m2 intravenously every 28 days
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma arising from the ovary, fallopian tubes, or peritoneum (i.e., peritoneal serous papillary adenocarcinoma)
- Received prior treatment with either cisplatin or carboplatin in combination with paclitaxel or docetaxel as first-line chemotherapy
- Radiographic evidence of progressive disease and/or a doubling of CA-125 levels ≥ 70 IU/mL following first-line chemotherapy
- Measurable disease as defined by RECIST criteria
- No CNS metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/μL
- Hemoglobin ≥ 9.5 g/dL
- Platelets \> 100,000/μL
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if liver metastases are present)
- LVEF ≥ 50% by MUGA
- Not pregnant or nursing
- +5 more criteria
You may not qualify if:
- Not specified
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior toxicities to ≤ grade 1 by NCI-CTC Version 2 criteria
- No other prior systemic therapies for this cancer except cisplatin or carboplatin in combination with paclitaxel or docetaxel as first-line chemotherapy
- More than 4 weeks since prior chemotherapy
- No concurrent anticancer therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (6)
Central Georgia Hematology Oncology Associates, P.C.
Macon, Georgia, 31201, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Jackson-Madison County Hospital
Jackson, Tennessee, 383013956, United States
St. Thomas Health Services
Nashville, Tennessee, 37205, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marta Crispens, M.D.
- Organization
- Vanderbilt-Ingram Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Marta Crispens, MD
Vanderbilt-Ingram Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor; Gynecological Oncologist
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 4, 2008
Study Start
May 1, 2003
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 23, 2012
Results First Posted
April 21, 2011
Record last verified: 2012-05