Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

NCT00186277 | Completed Phase 2 DMC

• 1 other identifier: BLDR0001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

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

  1 year

Interventions

Oxaliplatin DRUG

Calculated per patient

Also known as: Eloxatin

Taxotere DRUG

Calculated per patient

Also known as: Docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stanford University: lead
• Sanofi-Synthelabo: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Oxaliplatin; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Dr. Sandy Srinivas

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 30, 2011

Record last verified: 2011-03

Locations

US (1)