Clinical trial · Interventional
A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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
NCT00939809CI-TRIAL-00036530completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Ovarian Mixed Epithelial Tumor | — | UNRESOLVED | — |
| Ovarian Brenner Tumor | Ovarian Brenner Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Clear Cell Cystadenocarcinoma | Ovarian Clear Cell Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Endometrioid Adenocarcinoma | Ovarian Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Mucinous Cystadenocarcinoma | Ovarian Mucinous Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Serous Cystadenocarcinoma | Ovarian Serous Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Urokinase-Derived Peptide A6 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (urokinase-derived peptide A6)
- description
- Patients receive A6 subcutaneously once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: Urokinase-Derived Peptide A6
- Other: Laboratory Biomarker Analysis
Primary outcomes (3)
- measure
- Progression-free Survival at 6 Months
- timeFrame
- Scans to assess progression were done every other cycle for the first 6 months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 12 months, have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy * GOG performance status 0-2 (for patients who received 1 prior regimen) OR 0-1 (for patients who received 2 prior regimens) * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able and willing to self-administer daily subcutaneous (SC) injections or has a caregiver who is willing and able to administer daily SC injections * No active infection requiring antibiotics, except uncomplicated urinary tract infection * No neuropathy (sensory and motor) \> 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
References
Publications (0)
Data not yet available
No reference posted for this study.