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Phase 1/2 Study of Biweekly ALIMTA Plus Cisplatin in Patients With Locally, Advanced, Non-Resectable or Metastatic Urothelial Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Urologic Neoplasms

Thank you

Trial Information

Phase 1/2 Study of Biweekly ALIMTA Plus Cisplatin in Patients With Locally, Advanced, Non-Resectable or Metastatic Urothelial Cancer


Inclusion Criteria:



- Histologically proven locally advanced disease or metastatic transitional cell
carcinoma of the urothelium including bladder, urethra, ureter, and renal pelvis.
Patients should not be suitable for surgery or radiation with curative intent.
However patients whose pre-chemotherapy sites of disease are restricted to the
primary or regional lymph node sites and who have a major response to chemotherapy
will be evaluated for post-chemotherapy surgical resection of residual cancer if the
tumor has become resectable at the end of chemotherapy.

- Measurable disease status, as defined in the Response Evaluation Criteria in Solid
Tumors (RECIST) criteria (Therasse et al., 2000)

- One course of prior radiation therapy is allowed. Prior radiation must have been
completed at least 4 weeks before enrolment into the study and the patients must have
recovered from all toxic effects.

Exclusion Criteria:

- Have central nervous system (CNS) or leptomeningeal metastases (unless the patient
has completed successful local therapy for CNS metastases and has been off
corticosteroids for at least 4 weeks before starting study therapy). A screening
computed tomography (CT) or magnetic resonance imaging (MRI) before enrollment in the
absence of a clinical suspicion of brain metastases is not required.

- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents 2 days
before, the day of, and 2 days after the dose of pemetrexed plus cisplatin or
cisplatin alone. If a patient is taking a nonsteroidal anti-inflammatory drug
(NSAID) or salicylate with a long half-life (for example, naproxen, piroxicam,
diflunisal) it should not be taken 5 days before the dose of pemetrexed (8-day period
for long-acting agents such as piroxicam), the day of, and 2 days after the dose of
pemetrexed plus cisplatin.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best Overall Tumor Response

Outcome Description:

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.

Outcome Time Frame:

baseline to measured progressive disease (up to 620 days)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Spain: Ministry of Health

Study ID:

8679

NCT ID:

NCT00374868

Start Date:

August 2006

Completion Date:

April 2008

Related Keywords:

  • Urologic Neoplasms
  • Neoplasms
  • Urologic Neoplasms

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