Status:
TERMINATED
Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 chemother...
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 adenocarci...
Eligibility Criteria
Inclusion
- 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
- Negative pregnancy test
- Surgically sterile or must use effective contraception
- No known HIV positivity or AIDS
- No uncontrolled heart disease, diabetes, or other medical condition that would place the patient at unacceptably high risk for toxicity
- No New York Heart Association class I-IV heart failure
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00653328
Start Date
May 1 2003
End Date
March 1 2009
Last Update
May 23 2012
Active Locations (6)
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1
Central Georgia Hematology Oncology Associates, P.C.
Macon, Georgia, United States, 31201
2
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
3
The Jones Clinic
Germantown, Tennessee, United States, 38138
4
Jackson-Madison County Hospital
Jackson, Tennessee, United States, 383013956