Clinical trial NCT00050440: Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma
Official title: A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female Urogenital Neoplasms
Keywords: Endometrial
Cancer
Carcinoma
Trabectedin
Ecteinascidin 743
ET743
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PharmaMar
First posted: 2002-12-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.

Detailed description: Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the Investigator conducting this study. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced or metastatic endometrial carcinoma
* Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
* At least one measureable tumor lesion
* Adequate bone marrow, hepatic and renal function
* Performance status ECOG 0 or 1

Exclusion Criteria:

* Prior exposure to trabectedin
* Known hypersensitivity to dexamethasone or to any of the components of trabectedin
* Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
* History of another neoplastic disease unless in remission for more than 5 years
* Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
* Current pregnancy, lactation, or childbearing potential without adequate method of contraception.

Primary outcomes:
measure: Number of patients with objective response
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 3 years
measure: The number of patients with adverse events
timeFrame: Up to approximately 3 years
measure: Time to progression (TTP)
timeFrame: Up to approximately 3 years
measure: Progression free survival (PFS),
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Toronto
country: Canada
state: Ontario
city: Maastricht
country: Netherlands
city: Moscow N/A
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk N/A
country: Russian Federation
city: St Petersburg N/A
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St
country: Russian Federation
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: