Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00003276

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with advanced gallbladder or bile duct cancer that cannot be removed surgically.

Condition or Disease	Intervention/Treatment	Phase
Gallbladder Cancer	Drug: irinotecan hydrochloride	Phase 2

Detailed Description

OBJECTIVES: I. Evaluate the objective tumor response rate in patients with advanced gallbladder or bile duct tumors treated with irinotecan. II. Evaluate time-to-progression, survival, and toxic effects associated with irinotecan given weekly for 4 weeks every 6 weeks in this patient population.

OUTLINE: Patients receive a 90 minute continuous infusion of irinotecan on days 1, 8, 15, and 22 for 4 weeks, followed by a 2 week rest period. Courses of treatment are repeated every 42 days. Patients continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for the next 4 years.

PROJECTED ACCRUAL: Approximately 22-40 patients will be accrued for this study over 2-4 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors

Study Start Date :

Mar 1, 1998

Actual Primary Completion Date :

Mar 1, 2001

Actual Study Completion Date :

Mar 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Experimental: irinotecan Patients receive a 90 minute continuous infusion of irinotecan on days 1, 8, 15, and 22 for 4 weeks, followed by a 2 week rest period. Courses of treatment are repeated every 42 days. Patients continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for the next 4 years.	Drug: irinotecan hydrochloride

Arm

Intervention/Treatment

Experimental: irinotecan

Patients receive a 90 minute continuous infusion of irinotecan on days 1, 8, 15, and 22 for 4 weeks, followed by a 2 week rest period. Courses of treatment are repeated every 42 days. Patients continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for the next 4 years.

Drug: irinotecan hydrochloride

Outcome Measures

Primary Outcome Measures

objective tumor response rate [Up to 5 years]

Secondary Outcome Measures

overall survival [Up to 5 years]
time to progression [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically or cytologically proven gallbladder or bile duct carcinoma with metastatic or recurrent disease deemed unresectable and not considered a candidate for potentially curative therapy Measurable or evaluable disease No known active CNS disease Closed to bile duct carcinoma as of July 1999

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 5 times upper limit of normal (ULN) Bilirubin no greater than 1.5 mg/dL OR Bilirubin no greater than 2 times ULN in patients with biliary stents or percutaneous biliary catheters Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: Nutritional intake at least 1200 kcal/day No uncontrolled infection or chronic debilitating disease Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled seizure disorder No prior malignancy within 5 years except adequately treated basal cell/squamous cell carcinomas and adequately treated noninvasive carcinomas

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biological therapy or immunotherapy for recurrent or metastatic disease No concurrent biologic therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease Prior adjuvant chemotherapy allowed if used as a radiation sensitizer for completely resected disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent or metastatic disease Prior adjuvant radiotherapy allowed if used as a radiation sensitizer for completely resected disease No radiotherapy to greater than 25% of bone marrow No radiotherapy within the past 4 weeks No concurrent radiotherapy Concurrent CNS radiation allowed Surgery: No post abdominal exploration (with or without resection) within the past 4 weeks Other: No concurrent medication for other medical conditions except for: Analgesics Chronic treatments for preexisting conditions Agents required for life-threatening medical conditions No laxatives

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
3	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
4	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
5	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
6	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
7	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
8	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
9	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
10	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
11	CentraCare Clinic	Saint Cloud	Minnesota	United States	56303
12	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
13	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
14	Quain & Ramstad Clinic, P.C.	Bismarck	North Dakota	United States	58501
15	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
16	Altru Health Systems	Grand Forks	North Dakota	United States	58201
17	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
18	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
19	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
20	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080
21	Saskatchewan Cancer Agency	Regina	Saskatchewan	Canada	S4S 6X3

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: Steven R. Alberts, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00003276

Other Study ID Numbers:

NCCTG-964252
CDR0000066181

First Posted:

Apr 30, 2004

Last Update Posted:

Jul 6, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology

unresectable gallbladder cancer

recurrent gallbladder cancer

Additional relevant MeSH terms:

Gallbladder Neoplasms

Irinotecan

Study Results

No Results Posted as of Jul 6, 2016