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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00569673
First received: December 6, 2007
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: filgrastim
Biological: pegfilgrastim
Drug: docetaxel
Drug: trabectedin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Objective Tumor Response [ Time Frame: every other cycle for the first 6 months; then every 3 months x 2; then ] [ Designated as safety issue: No ]

    Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):

    Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.

    Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

    Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

    Stable Disease is any condition not meeting the above criteria.

    Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6


  • Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0 [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of Progression-free Survival and Overall Survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: March 2008
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00569673

  Show 37 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Bradley J. Monk, MD Chao Family Comprehensive Cancer Center
Investigator: Kristine M. Zanotti, MD MacDonald Physicians, Incorporated at University MacDonald Womens Hospital
  More Information

Additional Information:
Publications:
Monk, M BJ, Sill M, Walker JL, et al.: Activity of docetaxel plus trabectedin in recurrent or persistent ovarian and primary peritoneal cancer: A phase II study of the Gynecologic Oncology Group (GOG). [Abstract] J Clin Oncol 28 (Suppl 15): A-5046, 2010.

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00569673     History of Changes
Other Study ID Numbers: GOG-0186F, GOG-0186F, CDR0000577866
Study First Received: December 6, 2007
Results First Received: May 27, 2014
Last Updated: May 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Ovarian Neoplasms
Fallopian Tube Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Docetaxel
Trabectedin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2014