Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Molecular Mechanisms of Pharmacological Action; Trabectedin

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.