Clinical trial NCT00507741 (phase 2, status: completed)
Conditions: ovarian cancer, endometrial cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, N85.00, N85.01, N85.02, N99.85
Drugs: vintafolide, ertafolide
SMILES: [H][C@@]12N3CC[C@@]11C4=CC(=C(OC)C=C4N(C)[C@@]1([H])[C@](O)([C@H](O)[C@]2(CC)C=CC3)C(=O)NNC(=O)OCCSSC[C@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(O)=O)NC(=O)CC[C@H](NC(=O)C1=CC=C(NCC2=CNC3=NC(N)=NC(=O)C3=N2)C=C1)C(O)=O)C(O)=O)[C@]1(C[C@@]2([H])C[N@](C[C@](O)(CC)C2)CCC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility 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.