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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Biological: filgrastim
* Biological: pegfilgrastim
* Drug: docetaxel
* Drug: trabectedin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Biological: pegfilgrastim|nan|
|Drug: docetaxel|nan|
|Drug: trabectedin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumor Response | 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 | every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years) | 
| Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |  | Prior to each cycle and 30 days after the last cycle (average of 5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Progression-free Survival and Overall Survival |  | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer