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OpenTrials
Completed

NCT Number: NCT00186277

Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

To test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy in patients with advanced bladder cancer who have failed one prior chemotherapy.

Who can participate

Healthy volunteers accepted: No

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

  • Patient Population Type: Advanced Muscle Invasive Bladder Cancer
  • Prior Therapy: One prior therapy for advanced disease
  • Disease: Measurable disease
  • ECOG Performance: 0,1
  • Indication: Histologically Proven Carcinoma of the bladder
  • For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
  • Allergies: No known allergy to one of the study drugs
  • Patient Status:
  • No CNS metastases
  • No peripheral neuropathy > grade1
  • No other serious concomitant illness
  • Fully recovered from any prior therapy
  • Informed Consent: Patient and doctor have signed informed consent
  • Lower Age Limit: Lower age limit >18
  • Upper Age Limit: Upper Age Limit <70
  • ANC: ANC >1500/mm3 or WBC > 3000/mm3
  • Platelets: Platelets >100,000/mm3
  • Creatinine: Creatinine <1.8mg/dL
  • Bilirubin: Bilirubin <=2.0 x ULN
  • SGPT: SGPT (ALT) <=1.5 x ULN (<4xULN if liver metastases present)
  • RBC: Hemoglobin > 9.0g/dL
  • Cardiovascular: No active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months
  • Patients with metastatic cancer of the urothelial tract (TCC, Adenocarcinoma)
  • No prior exposure to Oxaliplatin
  • No cytotoxics or radiation 4 weeks prior to enrolling on protocol
  • PT/PTT normal

Treatment and study plan

Oxaliplatin

Drug

Calculated per patient

Other names: Eloxatin

Taxotere

Drug

Calculated per patient

Other names: Docetaxel

Primary outcomes

  1. Tolerability of the this combination in patients with recurrent metastatic bladder cancer.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Sanofi-Synthelabo

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Mar 30, 2011

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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