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A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

Phase 2
18 Years
Open (Enrolling)
Ovarian Carcinoma

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Trial Information

A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

STUDY DESIGN This is an open-label, phase II study. This study will utilize a Simon's
optimum two-stage design with early stopping rules. If at least 8 responses (at least 16%)
were observed among the 50 evaluable patients, this agent would be considered worthy of
further testing in this disease. If no more than 2 responses (no more than 10%) were
observed among the initial 21 patients, the study would be terminated early and declared

TREATMENT PLAN SJG-136 will be administered daily for 3 consecutive days every 3 weeks as a
20-minute intravenous infusion at a dose of 30 mcg/m2/day. Patients will be premedicated
with dexamethasone 8 mg po daily on days -1, 1, 2, and 3 of each cycle. Patients will be
closely monitored for the development of vascular leak syndrome. Patients will measure their
weight daily starting on Day 1 of Cycle 1 and will start aldactone at 50 mg/day orally if
weight increases by more than 2 lbs, or if grade 1 or worse peripheral edema or dyspnea
occurs, or if there is any increase in pre-existing edema. The primary endpoint is overall
response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)
1.1. The nature and degree of toxicity of SJG-136 in this patient population will be
assessed. Other parameters of response, including progression free survival (PFS), overall
survival (OS) and time to progression (TTP) will be assessed. Treatment will be continued
until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Inclusion Criteria:

- Patients must have persistent or recurrent epithelial ovarian, primary peritoneal, or
fallopian tube carcinoma, with histologic confirmation of the original primary tumor.

- Must have had at least one prior platinum-based (cisplatin or carboplatin)
chemotherapy regimen for the management of their primary disease. This would include
intraperitoneal chemotherapy.

- Patients must be considered platinum refractory or resistant, defined as patients
with progression of disease during platinum-based chemotherapy, patients having
persistent disease at the completion of platinum-based chemotherapy, or patients
having a disease free interval following prior platinum therapy of less than 6

- Patients may have had no more than 3 prior treatment regimens for their epithelial
ovarian, primary peritoneal or fallopian tube carcinoma. Consolidation or maintenance
therapy initiated within 6 weeks of the completion of primary therapy will not be
counted as an additional regimen.

- Must have measurable disease by RECIST 1.1 criteria.

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

- Time interval from last chemotherapy, radiotherapy, or surgery of at least four weeks
and the patient must have recovered from any significant adverse effects of prior
treatment. Patients must be ≥ 6 weeks from having received nitrosoureas or mitomycin

- Life expectancy > 3 months

- Patient must have adequate bone marrow and organ function, as defined below:

- Leukocyte count ≥ 3 x 10^9/L

- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Total bilirubin within normal institutional limits

- Aspartic transaminase (AST [SGOT])/alanine transaminase (ALT [SGPT]) ≤ 2.5 x
institutional upper limits of normal (ULN)

- Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance (ClCr) ≥ 60 ml/min by
Cockcroft Gault method

- Patients must have signed an approved informed consent.

- Patients of childbearing potential must have a negative serum pregnancy test prior to
study entry and must use an effective form of contraception.

- Patients must have archival tissue available from their original tumor debulking
surgery for assessment of BRCA1 protein expression.

Exclusion Criteria:

- Patients with borderline ovarian tumors, ovarian germ cell tumors, ovarian sex-cord
stromal tumors, or other non-epithelial ovarian tumors are not eligible.

- Patients receiving any other investigational agents

- Patients who have received radiation therapy to more than 25% of the bone marrow

- Patients who have previously received SJG-136 or related compounds

- Uncontrolled intercurrent illness including, but not limited to, ongoing active
infection, symptomatic congestive heart failure, unstable angina pectoris,
uncontrolled cardiac arrhythmias, or psychiatric illness/social situations that would
limit compliance with the study requirements

- Prior malignancy (other than cervical carcinoma in situ, ductal carcinoma in situ of
the breast, or non-melanoma skin cancer) unless treated with curative intent and
without evidence of disease for 3 years

- With the exception of alopecia (or other situations in which the organ dysfunction or
symptoms are considered clinically insignificant or irrelevant to the study),
patients may not have baseline organ dysfunction or symptoms that qualify as grade 2
or higher by the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria
for Adverse Events (CTCAE) v4.0. Particular attention should be paid to assessment of
pre-existing edema, since vascular leak syndrome was the dose limiting toxicity of
this agent in the phase I trial.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Overall Response Rate (ORR)

Outcome Description:

To estimate the overall response rate (ORR) to SJG-136 at a dose of 30 mcg/m2/day times three every 21 days in patients with persistent or recurrent, platinum-refractory or resistant epithelial ovarian, primary peritoneal, or fallopian tube carcinoma as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Outcome Time Frame:

Average of 6 months

Safety Issue:


Principal Investigator

Marta Ann Crispens, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

September 2013

Related Keywords:

  • Ovarian Carcinoma
  • cisplatin-refractory
  • resistant
  • epithelial
  • peritoneal
  • fallopian tube
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Hartford Hospital Cancer Clinical Research OfficeHartford, Connecticut  06102
Virginia Commonwealth University - VCU Massey Cancer CenterRichmond, Virginia  23298-0034