Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer (GEMCIRAV)
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with cisplatin and radiation therapy and to see how well they work in treating patients with stage II or stage III bladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: biopsy Procedure: cystoscopy Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder |
- Incidence and nature of acute and late toxicity (Phase I) [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: Yes ]
- Local tumor control (Phase II) [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
- Maximum tolerated dose and recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy (Phase I) [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: Yes ]
- 5- and 10-year survival (Phase II) [ Time Frame: until 5 and 10 year after the end of treatment ] [ Designated as safety issue: No ]
- Progression-free survival (Phase II) [ Time Frame: 6 to 8 weeks after to the end of treatment ] [ Designated as safety issue: No ]
- Quality of life (Phase II) [ Time Frame: From baselin to the end of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | June 2005 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| gemcitabine, cisplatine, radiotherapy | Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: biopsy Procedure: cystoscopy Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Detailed Description:
OBJECTIVES:
Primary
- Determine the incidence and nature of acute and late toxicity of gemcitabine hydrochloride, cisplatin, and concurrent radiotherapy in patients with stage II or III transitional cell carcinoma of the bladder. (Phase I)
- Determine the efficacy of this regimen, in terms of local tumor control (absence of local progression), in these patients. (Phase II)
Secondary
- Determine the maximum tolerated dose and the recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy in these patients. (Phase I)
- Assess the 5- and 10-year survival and the progression-free survival of patients treated with this regimen. (Phase II)
- Assess the quality of life of patients treated with this regimen. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride followed by a phase II, multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes twice weekly for 5 weeks and cisplatin IV continuously over 4 days on days 2-5 and 23-26 (weeks 1 and 4). Patients also undergo radiotherapy once daily 5 days a week for 5 weeks.
Three weeks after completion of treatment, patients undergo cystoscopy and transurethral resection (TUR). Patients with residual tumor or disease progression undergo radical TUR. After surgery, patients who achieve a complete response receive gemcitabine hydrochloride IV twice weekly for 2 weeks and cisplatin IV continuously over 4 days in week 1. Patients also undergo radiotherapy once daily 5 days a week for 2 weeks.
After completion of study treatment, patients are followed at 6-8 weeks and then 6 months thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of muscle invasive transitional cell carcinoma of the bladder
- T2-4a, N0, M0 (stage II or III disease)
- No adenocarcinoma or squamous cell carcinoma
PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-2 or Karnofsky PS 70-100%
- Life expectancy ≥ 6 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment
- No other prior malignancy, except previously treated nonmalignant skin cancer or carcinoma in situ of the cervix
- No prior serious digestive complications (e.g., ulcerative colitis or complicated diverticulosis)
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy (except for intravesical instillations)
Contacts and Locations| France | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Study Chair: | David Azria, MD, PhD | Centre Val d'Aurelle - Paul Lamarque |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Cancer Institute, France |
| ClinicalTrials.gov Identifier: | NCT00556621 History of Changes |
| Other Study ID Numbers: | CDR0000574107, CLCC_GEMCIRAV, INCA-RECF0285, GETUG-CLCC-GEMCIRAV |
| Study First Received: | November 9, 2007 |
| Last Updated: | December 11, 2012 |
| Health Authority: | France: L’Agence nationale de sécurité du médicament et des produits de santé |
Keywords provided by National Cancer Institute, France:
|
stage II bladder cancer stage III bladder cancer transitional cell carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Cisplatin Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013