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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00091195
Other study ID # NCI-2012-01036
Secondary ID CCCWFU 83403U10C
Status Terminated
Phase Phase 2
First received September 7, 2004
Last updated March 18, 2013
Start date September 2004

Study information

Verified date March 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase II trial is studying how well depsipeptide (romidepsin) works in treating patients with recurrent ovarian epithelial or peritoneal cavity cancer. Drugs used in chemotherapy, such as depsipeptide (romidepsin), work in different ways to stop tumor cells from dividing so they stop growing or die. Depsipeptide (romidepsin) may also stop the growth of ovarian epithelial or peritoneal cavity cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth


Description:

PRIMARY OBJECTIVES:

I. To estimate the response rate of recurrent, platinum-sensitive adenocarcinoma of the ovarian or peritoneal to depsipeptide (romidepsin).

II. To determine the toxicity of depsipeptide in this patient population.

OUTLINE: This is a multicenter study.

Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed up for 5 years.


Other known NCT identifiers
  • NCT01645670
  • NCT01660282

Recruitment information / eligibility

Status Terminated
Enrollment 51
Est. completion date
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed primary ovarian epithelial or peritoneal cavity cancer

- Histologic confirmation of recurrent disease not required

- Measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm by conventional techniques (including palpation, plain x-ray, computed tomography [CT] scan, or magnetic resonance imaging [MRI]) OR = 10 mm by spiral CT scan

- Achieved a complete response after initial prior platinum-containing (cisplatin or carboplatin) chemotherapy regimen (e.g., conventional-dose therapy, high-dose therapy, consolidation therapy, or extended therapy after surgical or nonsurgical assessment)

- Patients who have not received paclitaxel or docetaxel as initial therapy may receive a second regimen containing these drugs

- No prior chemotherapy for persistent or recurrent disease, including re-treatment with the original regimen

- Platinum-sensitive disease, defined as having a treatment-free interval with no evidence of progressive disease for > 6 but < 12 months after completion of a platinum-based regimen

- No known brain metastases

- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2

- Performance status - Karnofsky 60-100%

- More than 6 months

- White blood cells (WBC) = 3,000/mm^3

- Absolute neutrophil count = 1,500/mm^3

- Platelet count = 100,000/mm^3

- Bilirubin normal

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times upper limit of normal (ULN)

- Creatinine = 1.5 times ULN

- Creatinine clearance = 60 mL/min

- No New York Heart Association class III or IV congestive heart failure

- No myocardial infarction within the past year

- No uncontrolled dysrhythmias

- No poorly controlled angina

- No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation, = 3 beats in a row)

- QTc interval < 500 msec

- No other significant cardiac disease

- Potassium normal

- Magnesium normal

- No uncontrolled electrolyte abnormality (hypokalemia and hypomagnesemia)

- No ongoing or active infection requiring antibiotics

- No history of allergic reactions attributed to compounds of similar chemical or biological composition to study drug

- No neuropathy = grade 2

- No other uncontrolled illness

- No psychiatric illness or social situation that would preclude study compliance

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior monoclonal antibodies, cytokines, or signal transduction inhibitors for recurrent disease

- No concurrent biologic therapy

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for the primary malignancy

- No prior FR901228 (depsipeptide)

- No other concurrent chemotherapy

- More than 4 weeks since prior hormonal therapy for the primary malignancy

- Concurrent estrogen replacement therapy allowed

- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to > 25% of bone marrow

- No concurrent radiotherapy

- Recovered from all prior therapy

- More than 4 weeks since prior noncytotoxic therapy for the primary malignancy

- No other prior noncytotoxic therapy for recurrent disease

- No concurrent combination anti-retroviral therapy for HIV-positive patients

- No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g., valproic acid)

- No concurrent agents that cause QTc prolongation

- No other concurrent investigational agents

- No other concurrent anticancer agents

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
romidepsin


Locations

Country Name City State
United States High Point Regional Hospital High Point North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate Estimated as proportion of patients with complete or partial reduction in tumor burden. Up to 5 years No
Primary Toxicity as assessed by CTCAE version 3.0 Up to 5 years Yes
Primary Time to progression From first treatment until the date of progression, assessed up to 5 years No
Primary Survival From first treatment until death or the last date of contact, assessed up to 5 years No
See also
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Completed NCT00263822 - Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer Phase 3
Completed NCT00075712 - Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Phase 2/Phase 3
Completed NCT00012090 - Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum Phase 2
Completed NCT00003967 - Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00003636 - Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 3
Completed NCT00019552 - Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Phase 2
Active, not recruiting NCT00003160 - Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum Phase 2
Completed NCT00002538 - Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers Phase 2
Completed NCT00002600 - Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer Phase 1
Active, not recruiting NCT00838656 - Two Different Schedules of Carboplatin, Paclitaxel, Gemcitabine, and Surgery in Treating Patients With Newly Diagnosed Stage IIIC or Stage IV Primary Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Phase 2
Completed NCT00093496 - Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer Phase 2
Completed NCT00398138 - Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma Phase 1
Completed NCT00132067 - Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer Phase 2
Completed NCT00049556 - Gefitinib in Treating Patients With Cervical Cancer Phase 2
Terminated NCT00028782 - EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer N/A
Completed NCT00006942 - Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Phase 2
Completed NCT00003998 - Carboplatin Plus Paclitaxel or Docetaxel in Treating Patients With Ovarian Epithelial Cancer Phase 3
Completed NCT00003670 - Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer Phase 2
Completed NCT00003345 - Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Phase 2