Clinical trial NCT00101842: Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer
Official title: Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Transitional Cell
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-01-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven metastatic bladder cancer
* No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment
* Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment
* 18 years of age and older

Exclusion Criteria:

* Pure adeno- or squamous urothelial cancer
* Brain metastases that causes symptoms
* Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
* Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol
* Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled

Primary outcomes:
measure: Toxicity will be measured by standard grading methods.
Secondary outcomes:
measure: Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).
measure: Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause.
measure: Time to progressive disease is defined as time from enrollment to first date of disease progression.
measure: Time to treatment failure is defined as time from enrollment to first observation of disease progression, death of any cause or early discontinuation of treatment.
measure: Survival time is defined as time from enrollment to death from any cause.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: