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A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # Pending) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # Pending) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer



- 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.


- 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.

Inclusion Criteria


- 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

- 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)


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective tumor response

Safety Issue:


Principal Investigator

Bradley J. Monk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2008

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



CCOP - Christiana Care Health Services Wilmington, Delaware  19899
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
Rush University Medical Center Chicago, Illinois  60612-3824
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
UPMC Cancer Center at Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Alamance Cancer Center at Alamance Regional Medical Center Burlington, North Carolina  27216