Study of Vintafolide (MK-8109, EC145) in Participants With Advanced Ovarian and Endometrial Cancers (MK-8109-007, EC-FV-02)

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with advanced ovarian and endometrial cancers.

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

Details

• Lead Sponsor: Endocyte
• Treatments: Folic Acid; Vinca Alkaloids

Criteria

Part A:

Inclusion Criteria:

• Radiographic evidence of measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST]) and either:

• Advanced epithelial ovarian cancer with serous or endometrioid histology, as confirmed by previous biopsy or,

• ertafolide scan positive ovarian cancer, primary peritoneal cancer or adenocarcinoma of the endometrium.

• Prior treatment with platinum and/or taxane compounds.

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

• At least 4 weeks from prior therapy and recovered from associated acute toxicities.

• Adequate bone marrow reserve, renal, and hepatic function.

• Negative serum pregnancy test for women of childbearing potential and willingness to practice contraceptive methods.

Exclusion Criteria:

• Serious comorbidities (as determined by the Principal Investigator).

• Women who are pregnant or lactating.

• Symptomatic central nervous system (CNS) metastasis.

• Prior radiation therapy to assessable disease, unless disease progression is confirmed at that site.

• Requires palliative radiotherapy at time of study entry.

• Unable to tolerate conditions for radionuclide imaging.

• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational.

• Those who have been administered another radiopharmaceutical that would interfere with the assessment of 99mTc-ertafolide scan.

Part B:

Inclusion Criteria:

• Radiographic evidence of measurable disease (by RECIST criteria)

• ertafolide scan positive recurrent or persistent epithelial ovarian, primary fallopian tube, or peritoneal cancer.

• Prior treatment with platinum compounds, but not more than 4 prior cytotoxic chemotheraputic regimens.

• ECOG Performance status of 0-2.

• At least 3 weeks from prior cytotoxic therapy and recovered from associated acute toxicities.

• Adequate bone marrow reserve, renal, and hepatic function.

• Negative serum pregnancy test for women of childbearing potential and willingness to practice contraceptive methods.

Exclusion Criteria:

• Serious comorbidities (as determined by the Principal Investigator).

• Women who are pregnant or lactating.

• Symptomatic CNS metastasis.

• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational.

• Those who have had prior therapy with Vinorelbine or vinca-containing compounds.