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.

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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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

71

Study ID:

NCT00569673

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 37 Locations for this study

See Locations Near You

Providence Saint Joseph Medical Center - Burbank
Burbank California, 91505, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles California, 90095, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain Connecticut, 06050, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
St. Vincent Indianapolis Hospital
Indianapolis Indiana, 46260, United States
Union Hospital Cancer Program at Union Hospital
Elkton Maryland, 21921, United States
UMASS Memorial Cancer Center - University Campus
Worcester Massachusetts, 01655, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis Missouri, 63110, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87131, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington North Carolina, 27216, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus Ohio, 43210, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights Ohio, 44124, United States
Lake/University Ireland Cancer Center
Mentor Ohio, 44060, United States
Oklahoma University Cancer Institute
Oklahoma City Oklahoma, 73104, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Women and Infants Hospital of Rhode Island
Providence Rhode Island, 02905, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City Utah, 84112, United States
Carilion Gynecologic Oncology Associates
Roanoke Virginia, 24014, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

71

Study ID:

NCT00569673

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

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