Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

Brief Title

Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

Official Title

A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # 101018) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Brief Summary

      RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune
      system recover from the side effects of chemotherapy. Giving combination chemotherapy
      together with G-CSF or pegfilgrastim may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and
      trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or
      persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity
      cancer.

Detailed Description

      OBJECTIVES:

      Primary

        -  To estimate the antitumor activity of docetaxel plus trabectedin in patients with
           persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity
           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

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

      OUTLINE: Patients receive docetaxel IV over 1 hour and trabectedin IV over 3 hours on day 1.
      Patients also receive pegfilgrastim subcutaneously (SC) on day 1 OR filgrastim (G-CSF) IV
      over 15-30 minutes or SC once daily beginning on day 1 and continuing until blood counts
      recover. Treatment repeats every 3 weeks 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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Objective Tumor Response

Secondary Outcome

 Duration of Progression-free Survival and Overall Survival

Condition

Fallopian Tube Cancer

Intervention

filgrastim

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

March 2008

Primary Completion Date

January 2012

Eligibility Criteria

        DISEASE CHARACTERISTICS:

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

               -  Recurrent or persistent disease

          -  Measurable disease, defined as at least 1 lesion that can be accurately measured in at
             least 1 dimension (longest dimension to be recorded) ≥ 20 mm by conventional
             techniques or ≥ 10 mm by spiral CT scan

          -  Must have at least 1 "target lesion" to be used to assess response on this protocol 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 at least 90 days following completion of radiation therapy

          -  Must have had 1 prior platinum-based chemotherapeutic regimen for management of
             primary disease containing carboplatin, cisplatin, or another organoplatinum compound
             and the initial treatment may have included high-dose therapy, consolidation, or
             extended therapy administered after surgical or non-surgical assessment

               -  Patients are allowed, but not required to receive, 2 additional cytotoxic
                  regimens for management of recurrent or persistent disease with no more than 1
                  non-platinum, non-taxane regimen

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

                    -  Platinum-free interval of < 12 months

                    -  Progressed during platinum-based therapy

                    -  Persistent disease after a platinum-based therapy

          -  Not eligible for a higher priority GOG protocol (i.e., any active GOG Phase III
             protocol for the same patient population)

        PATIENT CHARACTERISTICS:

          -  GOG performance status (PS) 0-2 or after receiving 1 prior treatment regimen (GOG PS
             0-1 after receiving 2 or more prior regimens)

          -  Platelet count ≥ 100,000/mm³

          -  ANC count ≥ 1,500/mm³

          -  Hemoglobin > 9 g/dL

          -  Creatinine ≤ 1.5 times upper limit normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

          -  CPK normal

          -  Bilirubin or direct bilirubin normal

          -  Alkaline phosphatase normal

          -  Neuropathy (sensory and motor) ≤ grade 1

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection requiring antibiotics (except for uncomplicated UTI)

          -  No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer

          -  No known active liver disease or hepatitis

          -  Willing and able to have a central venous catheter

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

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

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

               -  Continuation of hormone replacement therapy allowed

          -  At least 3 weeks since other prior therapy, including biological and immunological
             therapy directed at the tumor

          -  Chimeric or human or humanized monoclonal antibodies must be discontinued for at least
             6 weeks prior to study entry

          -  No investigational therapy within the past 30 days

          -  No prior therapy with docetaxel and/or trabectedin

          -  No radiation to more than 25% of marrow-bearing areas

          -  No prior cancer treatment that contraindicates protocol therapy

Gender

Female

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Bradley J. Monk, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00569673

Organization ID

GOG-0186F

Secondary IDs

GOG-0186F

Responsible Party

Sponsor

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Bradley J. Monk, MD, Study Chair, Chao Family Comprehensive Cancer Center

Verification Date

May 2014