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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



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George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
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