Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01039207
First received: December 22, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This phase II trial is studying how well rilotumumab works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as rilotumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.


Condition Intervention Phase
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Biological: rilotumumab
Other: diagnostic laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of AMG 102 (Rilotumumab) (IND # 107579, NSC #750009) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Frequency of patients who survive progression-free for at least 6 months after study entry or have objective tumor response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of adverse effects as assessed by the NCI CTCAE [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Duration of PFS and overall survival (OS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (rilotumumab)
Patients receive rilotumumab IV over 30-60 minutes on days 1 and 14. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Tumor tissue and blood samples may be collected periodically for further laboratory analysis.
Biological: rilotumumab
Given IV
Other Names:
  • AMG 102
  • anti-HGF monoclonal antibody AMG 102
Other: diagnostic laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events associated with treatment with AMG 102 (rilotumumab) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

II. To determine the duration of progression-free survival (PFS) and overall survival (OS).

TERTIARY OBJECTIVES:

I. To explore the association between a panel of biomarkers (as assayed by immunohistochemistry and mutation analysis) and measures of response to treatment with AMG 102 (rilotumumab) and clinical outcome in archived tumor tissue.

II. 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 with AMG 102 (rilotumumab) and clinical outcome.

OUTLINE: This is a multicenter study.

Patients receive rilotumumab intravenously (IV) over 30-60 minutes on days 1 and 14. Courses repeat every 4 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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
  • 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
  • Recovered from prior surgery, radiotherapy, or chemotherapy
  • No prior cancer treatment that would contraindicate study treatment
  • No patients who have had previous treatment with AMG 102 (rilotumumab) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039207

  Show 28 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Lainie Martin Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01039207     History of Changes
Other Study ID Numbers: GOG-0170P, NCI-2011-01996, CDR0000662115, GOG-0170P, GOG-0170P, GOG-0170P, U10CA027469
Study First Received: December 22, 2009
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014