Phase 2
N=31
A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Fallopian Tube Carcinoma · Malignant Ovarian Mixed Epithelial Tumor · Ovarian Brenner Tumor · Ovarian Clear Cell Cystadenocarcinoma · Ovarian Endometrioid Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00939809 ↗Enrolled (actual)
31
Serious AEs
29.0%
Results posted
Jul 2014
Primary outcome: Primary: Progression-free Survival at 6 Months — 6.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Urokinase-Derived Peptide A6 (Biological); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival at 6 Months |
6.5 | — |
| PRIMARY Tumor Response |
— | — |
| PRIMARY Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 |
2; 1; 1 | — |
| SECONDARY Progression-free Survival |
2.0 | — |
| SECONDARY Overall Survival |
10.6 | — |
| SECONDARY Biomarkers of Drug Effect on Peripheral Blood Mononuclear Cells (PBMCs) |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma, including any of the following epithelial cell types:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell carcinoma
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Must have ≥ 1 target lesion to assess response as defined by RECIST criteria
- Tumors within a previously irradiated field are designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence of disease ≥ 90 days following completion of radiotherapy
- Must not be eligible for a higher priority GOG clinical trial, if one exists (i.e., any active GOG Phase III clinical trial for the same patient population)
- Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
- Initial treatment may have included high-dose therapy, consolidation therapy, non-cytotoxic therapy, or extended therapy administered after surgical or non-surgical assessment
- One additional cytotoxic regimen for management of recurrent or persistent disease allowed
- Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease) must have a platinum-free interval of grade 2, according to CTCAE v3.0
- No other invasive malignancies within the past 5 years, except for non-melanoma skin cancer
- No history of sensitivity to A6
- No active gastrointestinal bleeding within the past month
- No other disease that, in the opinion of the investigator, could jeopardize patient safety or interfere with study objectives
- No concurrent amifostine or other protective reagents
- Recovered from prior surgery, radiotherapy, or chemotherapy
- No prior non-cytotoxic therapy for management of recurrent or persistent disease
- Prior biologic (non-cytotoxic) therapy as part of primary treatment regimen allowed
- At least 1 week since prior hormonal therapy directed at the malignant tumor
- At least 3 weeks since any other prior therapy directed at the malignant tumor, including immunological agents
- More than 2 weeks since prior major surgical procedure
- More than 5 years since prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer
- More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin AND remains free of recurrent or metastatic disease
- Patients with ductal breast carcinoma in situ may have undergone localized radiotherapy within the past 3 years
- More than 5 years since prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer
- More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND remains free of recurrent or metastatic disease
- More than 30 days since prior investigational drugs
- No prior A6
- No prior radiotherapy to > 25% of marrow-bearing areas
- No prior cancer treatment that would contraindicate study therapy
Data sourced from ClinicalTrials.gov (NCT00939809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.