Know Cancer

or
forgot password

A Phase II Evaluation of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma

Thank you

Trial Information

A Phase II Evaluation of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer


OBJECTIVES:

Primary

- To estimate the proportion of patients who survive progression-free for ≥ 6 months and
the proportion of patients who have objective tumor response (complete or partial) in
patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary
peritoneal carcinoma treated with intraperitoneal EGEN-001.

- To determine the frequency and severity of adverse events as assessed by the NCI CTCAE
version 4.0.

Secondary

- To determine the duration of progression-free survival and overall survival.

Tertiary

- To collect blood and peritoneal lavage fluid from patients that will be stored for
future research.

OUTLINE: This is a multicenter study.

Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.

Blood and peritoneal fluid samples may be collected at baseline for translational research.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
carcinoma

- Recurrent or persistent disease

- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded) as ≥ 10 mm by CT scan, MRI, or caliper
measurement by clinical exam or as ≥ 20 mm by chest x-ray

- Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

- Patients must have evidence of intraabdominal/pelvic disease

- No patients with disease exclusively located outside of the abdomen/pelvic
cavity

- At least 1 "target lesion" to be used to assess response

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days after completion of radiotherapy

- Not eligible for a higher priority GOG trial, if one exists (e.g., any active GOG
phase III trial for the same patient population)

- Received 1 prior platinum-based chemotherapeutic regimen for management of primary
disease containing carboplatin, cisplatin, or another organoplatinum compound (this
initial treatment may have included intraperitoneal therapy, consolidation,
noncytotoxic agents, or extended therapy administered after surgical or nonsurgical
assessment)

- Patients who have received only 1 prior cytotoxic regimen (platinum-based
regimen for the management of primary disease) must meet 1 of the following
criteria:

- Platinum-free interval < 12 months

- Progressed during platinum-based therapy

- Persistent disease after a platinum-based therapy

PATIENT CHARACTERISTICS:

- GOG performance status 0-2 (for patients who have received 1 prior regimen) OR 0-1
(for patients who have received 2 prior regimens)

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance
≥ 50 mL/min

- Bilirubin ≤ 1.5 times ULN

- AST ≤ 3 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics (except for uncomplicated urinary tract
infection)

- Any evidence of renal obstruction must be corrected before study treatment

- No neuropathy (sensory or motor) > CTCAE grade 1

- No history of other invasive malignancies, except for any of the following:

- Nonmelanoma skin cancer

- Localized cancer of the breast, head and neck, or skin provided there is no
evidence of the disease for ≥ 3 years

- No history of endometrial cancer unless all of the following criteria are met:

- Stage not greater than IB

- No more than superficial myometrial invasion without vascular or lymphatic
invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesions

- No serious uncontrolled medical illness or disorder or active infection within the
past 4 weeks

- No condition or anomaly that would interfere with the appropriate placement of the
intraperitoneal catheter for study drug administration, including intestinal
dysfunction or suspected extensive adhesions from prior history or finding at
laparoscopy

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- One additional cytotoxic regimen for the management of recurrent or persistent
disease is allowed

- Cytotoxic regimens include any agent that targets the genetic and/or mitotic
apparatus of dividing cells, resulting in dose-limiting toxicity to the bone
marrow and/or gastrointestinal mucosa

- Patients on this study may receive additional cytotoxic chemotherapy for the
management of recurrent or persistent disease, as defined above

- Patients are allowed to receive, but are not required to receive, biologic/targeted
therapy as part of their primary treatment regimen

- Patients are allowed to receive, but are not required to receive, one
biologic/targeted therapy for recurrent disease (either alone or in combination with
chemotherapy)

- Recovered from the effects of recent surgery, radiotherapy, or chemotherapy

- No prior EGEN-001

- No prior cancer treatment that contraindicates study treatment

- More than 3 years since prior chemotherapy for any abdominal or pelvic tumor OTHER
THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

- Prior adjuvant chemotherapy for localized breast cancer is allowed provided that
it was completed > 3 years ago and that the patient remains free of recurrent or
metastatic disease

- More than 3 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

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is
allowed provided that it was completed > 3 years ago and that the patient
remains free of recurrent or metastatic disease

- More than 4 weeks since prior abdominal surgery (for reasons other than
intraperitoneal port placement)

- At least 1 week since surgery for the purpose of intraperitoneal port placement

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- Continuation of hormone replacement therapy is allowed

- Any other prior therapy directed at the malignant tumor, including chemotherapy,
biologic/targeted therapy, and immunologic agents, must be discontinued at least 3
weeks prior to registration

- No concurrent amifostine or other protective reagents

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who survive progression-free for ≥ 6 months

Outcome Time Frame:

6 months post treatment iniation

Safety Issue:

No

Principal Investigator

Philip J. DiSaia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

GOG-0170Q

NCT ID:

NCT01118052

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • recurrent ovarian epithelial cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cavity cancer
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045