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OpenTrials
Completed

NCT Number: NCT00101842

Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer

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.

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Key information

Conditions

Carcinoma, Transitional Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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.

Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

Gemcitabine

Drug

Platinol

Drug

Primary outcomes

  1. Toxicity will be measured by standard grading methods.

Secondary outcomes

  1. Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).

  2. 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.

  3. Time to progressive disease is defined as time from enrollment to first date of disease progression.

  4. 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.

  5. Survival time is defined as time from enrollment to death from any cause.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer

Important dates

Study start
2004
Study completion
2006
First posted
Jan 17, 2005
Registry last updated
Aug 29, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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