Ovarian Cancer Clinical Trial
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
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.
Full 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 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 37 Locations for this study
Burbank California, 91505, United States
Los Angeles California, 90095, United States
New Britain Connecticut, 06050, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Savannah Georgia, 31403, United States
Chicago Illinois, 60612, United States
Hinsdale Illinois, 60521, United States
Indianapolis Indiana, 46260, United States
Elkton Maryland, 21921, United States
Worcester Massachusetts, 01655, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87131, United States
Burlington North Carolina, 27216, United States
Charlotte North Carolina, 28232, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43222, United States
Dayton Ohio, 45409, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Oklahoma City Oklahoma, 73104, United States
Abington Pennsylvania, 19001, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Providence Rhode Island, 02905, United States
Salt Lake City Utah, 84112, United States
Roanoke Virginia, 24014, United States
Madison Wisconsin, 53792, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.