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
71
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