Status:
COMPLETED
A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Carcinoma
Malignant Ovarian Mixed Epithelial Tumor
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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....
Detailed Description
PRIMARY OBJECTIVES: I. To assess the activity of A6, as measured by the 6-month progression-free survival (PFS) rate and objective tumor response (complete or partial) rate, in patients with persiste...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00939809
Start Date
July 1 2009
Last Update
January 15 2019
Active Locations (16)
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1
Georgia Regents University Medical Center
Augusta, Georgia, United States, 30912
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
4
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794