Know Cancer

or
forgot password

A Phase II Evaluation of a Urokinase-Derived Peptide (A6) (IND #64,298) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of a Urokinase-Derived Peptide (A6) (IND #64,298) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


OBJECTIVES:

Primary

- 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
persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal
carcinoma.

- To determine the frequency and severity of adverse events as assessed by CTCAE v3.0.

Secondary

- To characterize the duration of PFS and overall survival.

- To identify biomarkers of drug effect on peripheral blood mononuclear cells (PBMCs).

Tertiary

- To explore whether genes identified as being up- or down-regulated by exposure of human
PBMCs to A6 in vitro are also up- or down-regulated following treatment of patients
with A6 in vivo.

- To explore whether there is an association between the expression of candidate A6
receptors in the tumor prior to treatment with A6 (as determined by IHC) and response
and PFS.

- To explore whether there is an association between change in expression of candidate
biomarkers in PBMCs between 0-24 hours following the first dose of A6 and response and
PFS.

- To explore whether there is an association between change in expression of candidate
biomarkers in PBMCs over the course of the first one month cycle (course 1) and
response and PFS.

- To determine whether there is an association between plasma A6 levels measured on days
2 (24 hours after the first dose and 4 hours after the second dose) and 8 (prior to
injection of A6) of course 1 and levels of expression of candidate biomarkers in PBMCs
collected on the same days.

- To explore whether there is an association between plasma A6 levels measured on days 2
(24 hours after the first dose and 4 hours after the second dose) and 8 (prior to
injection of A6) of course 1 and response and PFS.

- To explore whether there is an association between candidate serum biomarkers and
response and PFS over the course of A6 treatment.

OUTLINE: This is a multicenter study.

Patients receive A6 subcutaneously once daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- 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

- No concurrent amifostine or other protective reagents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month progression-free survival rate

Safety Issue:

No

Principal Investigator

Michael A. Gold, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt Medical Group & Clinic at Vanderbilt Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000644399

NCT ID:

NCT00939809

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • ovarian clear cell cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • recurrent ovarian epithelial cancer
  • Brenner tumor
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Black Hills Obstetrics & Gynecology LLPRapid City, South Dakota  57701