Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors (ABC-02)
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| ClinicalTrials.gov Identifier: NCT00262769 |
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Recruitment Status :
Completed
First Posted : December 7, 2005
Last Update Posted : July 17, 2012
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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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors.
PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Extrahepatic Bile Duct Cancer Gallbladder Cancer | Drug: cisplatin Drug: gemcitabine hydrochloride | Phase 3 |
OBJECTIVES:
Primary
- Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochloride with vs without cisplatin.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary site of disease (gallbladder vs bile ducts vs ampulla), prior therapy (photodynamic therapy [PDT] vs non-PDT therapy vs none), ECOG performance status (0 vs 1 vs 2), and disease status (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1½ hours on days 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 12 weeks, and after finishing treatment.
After completion of study treatment, patients are followed periodically for at least 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 324 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | August 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A - Gemcitabine
Gemcitabine alone
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Drug: gemcitabine hydrochloride
1000mg/m2 in 250-500mls 0.9% saline over 30 mins by intravenous infusions on day 1, 8 and 15 (Arm A only) of each 28 (Arm A) or 21 (Arm B) day cycle.
Other Name: Gemzar |
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Experimental: B - Gemcitabine and Cisplatin
Gemcitabine and Cisplatin
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Drug: cisplatin
25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins
Other Names:
Drug: gemcitabine hydrochloride 1000mg/m2 in 250-500mls 0.9% saline over 30 mins by intravenous infusions on day 1, 8 and 15 (Arm A only) of each 28 (Arm A) or 21 (Arm B) day cycle.
Other Name: Gemzar |
- Overall Survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ]From date of randomisation till date of death or last date of follow-up (up to 5 years)
- Progression-free survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ]From date of randomisation till date of death or last date of follow-up (up to 5 years)
- Quality of life [ Time Frame: Before and 12 weeks after completion of treatment ]Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically
- Toxicity [ Time Frame: During treatment and follow-up ]Toxicity as measured by NCI CTC periodically. The proportion of patients who experience a toxicity of grade 3 or 4 will be compared between the two arms of the trial.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma
- Intra- or extra-hepatic disease allowed
- Unresectable locally advanced, recurrent, or metastatic disease
- No brain metastases
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- WBC ≥ 3,000/mm^3
Hepatic
- AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Bilirubin ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)
- Adequate biliary drainage
- No unresolved biliary tract obstruction
Renal
- Creatinine < 1.5 times ULN
- Urea < 1.5 times ULN
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Glomerular filtration rate (GFR) ≥ 45 mL/min
- If GFR < 60 mL/min, isotope EDTA confirmation of adequate renal function is required
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No active, uncontrolled infection
- No other severe or uncontrolled systemic disease
- No other malignancy within the past 5 years except nonmetastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection
- No psychiatric disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 6 months since prior adjuvant chemotherapy
- No prior gemcitabine hydrochloride
- No prior cisplatin
- No prior systemic chemotherapy for locally advanced or metastatic disease except low-dose radiosensitizing chemotherapy in conjunction with radiotherapy
Radiotherapy
- Prior radiotherapy for localized disease allowed provided there is clear evidence of disease progression afterwards
Surgery
- Prior curative surgery allowed provided there is evidence of nonresectable disease relapse requiring systemic chemotherapy
Other
- Recovered from all prior therapies
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Prior photodynamic therapy (PDT) allowed provided it was given for localized disease only (with no evidence of metastatic disease) and resulted in subsequent disease progression after completion of therapy OR to relieve biliary obstruction in the presence of metastatic disease
- PDT must have been completed ≥ 4 weeks ago
- At least 4 weeks since prior investigational agents
- No other concurrent, curative anticancer therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262769
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| Study Chair: | John A. Bridgewater | University College London (UCL) Cancer Institute |
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT00262769 |
| Other Study ID Numbers: |
CDR0000455013 CRUK-ABC-02 EU-205103 ISRCTN82956140 EUDRACT-2004-004882-14 CTA-21266/0005/001 |
| First Posted: | December 7, 2005 Key Record Dates |
| Last Update Posted: | July 17, 2012 |
| Last Verified: | July 2012 |
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cholangiocarcinoma of the extrahepatic bile duct recurrent extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer cholangiocarcinoma of the gallbladder |
recurrent gallbladder cancer unresectable gallbladder cancer metastatic extrahepatic bile duct cancer metastatic gallbladder cancer |
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Cholangiocarcinoma Gallbladder Neoplasms Bile Duct Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site |
Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Bile Duct Diseases Cisplatin Gemcitabine Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |