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A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Urothelial Carcinoma

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Trial Information

A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR


Inclusion Criteria:



- Histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with
the exception of micropapillary subtype

- Patients must have recurrent disease (locally advanced or metastatic) that is not
amenable to local therapy or newly diagnosed distant metastatic disease

- Measurable disease defined by RECIST v.1.0

- ECOG performance status of 2 or better

- Adequate organ and bone marrow function defined as

Exclusion Criteria:

- Other tumor type than urothelial carcinoma

- Presence or history of CNS metastasis

- Prior systemic chemotherapy or immunotherapy (but prior local intravesical
chemotherapy or immunotherapy was allowed. And recurrent disease after adjuvant or
neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy
was administered 1 year or more before the patient enrollment.)

- Presence of second primary malignancy (except in situ carcinoma of the cervix or
adequately treated basal cell carcinoma of the skin)

- Peripheral sensory neuropathy grade 2 or worse

- Other serious illness or medical conditions

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Based on RECIST v.1.0

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

UOSG-AMC-0804

NCT ID:

NCT01490437

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Urothelial Carcinoma
  • Advanced urothelial carcinoma
  • Carcinoma
  • Carcinoma, Transitional Cell

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