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A Phase II Evaluation of a Urokinase-Derived Peptide (A6) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
This phase II trial is studying the side effects and how well A6 works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. A6 may stop the growth of tumor cells by blocking blood flow to the tumor.
Details
| Lead sponsor | Gynecologic Oncology Group |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 31 |
| Start date | 2009-07 |
Conditions
- Fallopian Tube Carcinoma
- Malignant Ovarian Mixed Epithelial Tumor
- Ovarian Brenner Tumor
- Ovarian Clear Cell Cystadenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Mucinous Cystadenocarcinoma
- Ovarian Serous Cystadenocarcinoma
- Primary Peritoneal Carcinoma
- Recurrent Ovarian Carcinoma
- Undifferentiated Ovarian Carcinoma
Interventions
- Urokinase-Derived Peptide A6
- Laboratory Biomarker Analysis
Primary outcomes
- Progression-free Survival at 6 Months — Scans to assess progression were done every other cycle for the first 6 months.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response. - Tumor Response — Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.
Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response. - Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 — Every cycle during treatment (average collection time = 4 months)
Countries
United States