Protocol No. HCI IRB # 28711, GOG 0186F

A PHASE II EVALUATION OF DOCETAXEL (NSC #62803) PLUS TRABECTEDIN (Yondelis®, R279741, IND #101018) WITH GROWTH FACTOR SUPPORT IN THE TREATMENT OF RECURRENT OR PERSISTENT OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER

Objectives

Primary Objective(s):

  • To estimate the antitumor activity of docetaxel plus trabectedin (YONDELIS®, R279741, formerly referred to as ET-743) in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer primarily through the frequency of objective tumor responses.
  • To determine the nature and degree of toxicity of docetaxel plus trabectedin in this cohort of patients.

Secondary Objective(s):

  • To estimate the progression-free survival and overall survival of patients treated with docetaxel and trabectedin.

Contact Information

Status: Open to Enrollment

HCI Information Services
801-581-6365 (in Salt Lake City)
1-888-424-2100 (toll free)

clinical.trials@hci.utah.edu

Please Note:

This posting is a summary of the basic requirements for participation in this study, and it is not intended to provide all the information needed to decide whether or not to participate.

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.

Although the studies described on this Web site may have potential benefits as described, Huntsman Cancer Institute and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.


Participant Eligibility

Inclusion Criteria:
All patients must have cancer and meet the following criteria to be enrolled into the study:

  1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
  2. All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be t 20mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or t 10 mm when measured by spiral CT.
  3. Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST. 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 at least 90 days following completion of radiation therapy.
  4. Patients must not be eligible for a higher priority GOG protocol, if one exists. In general, this would refer to any active GOG Phase III protocol for the same patient population
  5. Patients who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2.
  6. Patients who have received two or three prior regimens must have a GOG Performance Status of 0 or 1.
  7. Patients must be > 18 years of age.
  8. Must have an ECOG/Zubrod performance status 0, 1, or 2.
  9. Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
    1. Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
    2. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
    3. Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration; six weeks for patients previously treated with monoclonal antibodies. No investigational therapy within 30 days prior to the first date of study treatment.
  10. Prior therapy
    1. Patients must have had one 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, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
    2. Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum, non-taxane regimen. Patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy either alone or as part of the cytotoxic regimens for management of recurrent or persistent disease.
    3. Patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen.
    4. Patients who have received only one prior cytotoxic regimen (platinum¬based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy.
  11. Patients must have adequate: Bone marrow function; Hemoglobin; Renal function; Hepatic function AST and ALT; Alkaline Phosphatase must be within ULN; Neurologic function; as defined by the protocol.
  12. Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  13. Patients must meet pre-entry requirements as specified in the protocol
  14. Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing an effective form of contraception.

Exclusion Criteria:
Patients who meet any of the following criteria may not be enrolled into the study:

  1. Patients who have had prior therapy with docetaxel and/or trabectedin.
  2. Patients who have received radiation to more than 25% of marrow-bearing areas.
  3. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in Sections 3.24 and 3.25, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
  4. Patients who have received 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 last five years are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  5. Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last five years are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
  6. Patients who are unwilling/unable to have a central venous catheter.
  7. Patients who have known active liver disease or hepatitis.

How long does the study run?

This study is open to enrollment.

Locations(s) of the Clinical Trial

Huntsman Cancer Institute, Salt Lake City, Utah