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A Phase II Evaluation of AMG 102 (IND # 107579, NSC #750009) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Malignant Tumor of Peritoneum

Thank you

Trial Information

A Phase II Evaluation of AMG 102 (IND # 107579, NSC #750009) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


OBJECTIVES:

Primary

- To estimate the 6-month progression-free survival (PFS) rate in patients with
persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal
carcinoma treated with fully human anti-HGF monoclonal antibody AMG 102.

- To estimate the objective tumor response (complete or partial response) rate in
patients treated with this drug.

Secondary

- To determine the frequency and severity of adverse events associated with this drug in
these patients.

- To determine the duration of PFS and overall survival of patients treated with this
drug.

Tertiary

- To explore the association between a panel of biomarkers (as assayed by IHC and
mutation analysis) and measures of response to treatment and clinical outcome in
archived tumor tissue. (Translational)

- To evaluate circulating pre- and post-treatment levels of hepatocyte growth
factor/scatter factor and markers of angiogenesis, and their association with response
to treatment and clinical outcome. (Translational)

OUTLINE: This is a multicenter study.

Patients receive fully human anti-HGF monoclonal antibody AMG 102 IV over 30-60 minutes on
day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable
toxicity.

Tumor tissue and blood samples may be collected periodically for further laboratory
analysis.

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

- Histologic confirmation of the original primary tumor via pathology report
required

- 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 ≥ 20 mm by chest x-ray

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

- Has ≥ 1 "target lesion" to be used to assess response, as defined by RECIST criteria

- 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 following completion of radiotherapy

- 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 intraperitoneal therapy, high-dose therapy,
consolidation therapy, non-cytotoxic agents, or extended therapy administered
after surgical or non-surgical assessment

- Must have a platinum-free interval of < 12 months, progressed during
platinum-based therapy, or have persistent disease after platinum-based therapy

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

- Ineligible for a higher priority GOG protocol, if one exists (e.g., any active GOG
phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

- GOG performance status (PS) 0-2 (for patients who received 1 prior regimen)

- GOG PS 0-1 (for patients who received 2 prior regimens)

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- PTT ≤ 1.5 times ULN

- INR ≤ 1.5 times ULN

- Proteinuria ≤ 1+ by urinalysis OR ≤ 1 g/24 hrs by 24-hour urine collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No neuropathy (sensory or motor) > grade 1

- No peripheral edema or lymphedema > grade 2

- No active bleeding diathesis

- No thromboembolic or ischemic event within the past 12 months, including any of the
following:

- Deep venous thrombosis

- Pulmonary embolism

- Transient ischemic attack

- Cerebral infarction

- Myocardial infarction

- No serious or non-healing wound

- No known HIV or hepatitis C positivity or chronic or active hepatitis B

- No active infection requiring antibiotics

- Uncomplicated urinary tract infection allowed

- No other concurrent serious infection or nonmalignant medical illness that is
uncontrolled or whose control may be jeopardized by study treatment

- No psychiatric condition or other condition that would preclude giving informed
consent or meeting study requirements

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

- No greater than stage IB disease

- No more than superficial myometrial invasion

- No vascular or lymphatic invasion

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

- No other invasive malignancies within the past 3 years except for nonmelanoma skin
cancer or localized cancer of the breast, head and neck, or skin

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior surgery, radiotherapy, or chemotherapy

- No prior cancer treatment that would contraindicate study treatment

- No prior fully human anti-HGF monoclonal antibody AMG 102 or other HGF/c-met pathway
inhibitors

- No prior non-cytotoxic therapy for management of recurrent or persistent disease

- Prior biologic (non-cytotoxic) therapy as part of primary treatment regimen
allowed

- No prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for
the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the
past 3 years

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

- No prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment
of ovarian, fallopian tube, or primary peritoneal cancer within the past 3 years

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

- More than 30 days since prior surgery (14 days for minor surgical procedures)

- Central venous catheter placement allowed at any time point before study
enrollment provided the patient has recovered and any surgical wound has healed

- 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 immunologic agents

- More than 7 days since prior and no concurrent therapeutic anti-coagulation therapy
with warfarin, heparin, or low molecular weight heparin

- Low-dose warfarin (≤ 2 mg orally daily) for prophylaxis against central venous
catheter thrombosis allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) rate at 6 months

Safety Issue:

No

Principal Investigator

Lainie Martin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

Unspecified

Study ID:

CDR0000662115

NCT ID:

NCT01039207

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Malignant Tumor of Peritoneum
  • fallopian tube cancer
  • peritoneal cavity cancer
  • recurrent ovarian epithelial cancer
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
McFarland Clinic, PCAmes, Iowa  50010
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Gynecologic OncologyHinsdale, Illinois  60521
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
All Saints Episcopal Hospital - Fort WorthFort Worth, Texas  76104