A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
18 Years
N/A
Female
Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer
Trial Information
A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
PRIMARY OBJECTIVES:
I. To estimate the overall response rate to SJG-136 in patients with persistent or recurrent
platinum-refractory epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
II. To assess the nature and degree of toxicity of this regimen in these patients.
III. To determine other parameters of response, including progression-free survival, overall
survival, and time to progression in patients treated with this regimen.
SECONDARY OBJECTIVES:
I. To correlate response rates with the degree of DNA adduct formation in peripheral blood
mononuclear cells (PBMCs) and tumor cells as measured by the single-cell gel electrophoresis
(Comet) assay and γ-H2AX assay.
II. To assess whether the rate of DNA adduct formation in PBMCs correlates with the rate of
DNA adduct formation in tumor cells.
III. To evaluate BRCA1 protein expression in archival tissue specimens from the patient's
primary tumor reductive surgery.
IV. To determine the ability of BRCA1 protein in repairing/removing DNA-adducts in PBMCs and
tumor tissue.
VI. To evaluate the effect of BRCA1 protein expression on the overall response rate to
SJG-136.
OUTLINE: This is a multicenter study.
Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for
correlative studies. Tumor tissue samples may also be collected.
After completion of study therapy, patients are followed up for 30 days and then annually
thereafter.
Inclusion Criteria:
- Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube
carcinoma
- Persistent or recurrent disease
- No borderline ovarian tumors, ovarian germ cell tumors, ovarian sex-cord stromal
tumors, or other non-epithelial ovarian tumors
- Must have had >= 1 prior platinum-based (cisplatin or carboplatin) chemotherapy
regimen for the management of primary disease
- Intraperitoneal chemotherapy allowed
- Platinum-refractory or -resistant meeting 1 of the following criteria:
- Progression of disease during platinum-based chemotherapy
- Persistent disease at the completion of platinum-based chemotherapy
- Less than 6 months of disease-free interval after completion of platinum-based
therapy
- Measurable disease
- Archived tissue available from the original tumor debulking surgery for assessment of
BRCA1 protein expression
- ECOG performance status 0-2
- Life expectancy > 3 months
- WBC >= 3,000/mm^3
- ANC >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Total bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal
- Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min
- Negative pregnancy test
- Fertile patients must use effective contraception during and for >= 3 months after
completion of study therapy
- No uncontrolled intercurrent illness including, but not limited to, any of the
following:
- Ongoing active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Uncontrolled cardiac arrhythmia
- Psychiatric illness and/or social situations that would limit compliance with
the study requirements
- No prior malignancy except cervical carcinoma in situ, ductal carcinoma in situ of
the breast, nonmelanoma skin cancer, or curatively treated malignancy without
evidence of disease within the past 3 years
- No baseline organ dysfunction or symptoms that qualify as >= grade 2 by CTEP CTCAE v
4.0
- Alopecia or other situations in which the organ dysfunction or symptoms are
considered clinically insignificant or irrelevant to the study allowed
- No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy,
radiotherapy, or surgery for cancer (including resection of metastases)
- No more than 3 prior treatment regimens for epithelial ovarian, primary peritoneal,
or fallopian tube carcinoma
- Consolidation or maintenance therapy initiated within 6 weeks after the
completion of primary therapy will not be counted as an additional regimen
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C),
radiotherapy, or surgery and recovered
- No prior radiotherapy to > 25% of the bone marrow
- No prior SJG-136 or related compounds
- No other concurrent investigational agents
- No concurrent palliative radiotherapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Description:
The exact 95% confidence interval of the response rate will be reported.
Outcome Time Frame:
Up to 30 days
Safety Issue:
No
Principal Investigator
Marta Crispens
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2011-02519
NCT ID:
NCT01200797
Start Date:
July 2010
Completion Date:
Related Keywords:
- Recurrent Fallopian Tube Cancer
- Recurrent Ovarian Epithelial Cancer
- Recurrent Primary Peritoneal Cavity Cancer
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
- Neoplasms, Glandular and Epithelial
- Ovarian Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Vanderbilt University | Nashville, Tennessee 37232-6305 |
| Virginia Commonwealth University | Richmond, Virginia |
| Oncology Associates PC | Hartford, Connecticut 06106 |
