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Gallbladder CancerPhase 2NCT00003276

Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

A Phase 2 study testing irinotecan hydrochloride in people with Gallbladder Cancer, run by Alliance for Clinical Trials in Oncology at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gallbladder Cancer
What is being tested?
irinotecan hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
21 sitesin 2 countries
Study dates
Mar 1998to Mar 2001
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States20 sites

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Quain & Ramstad Clinic, P.C.

    Bismarck, North Dakota, 58501

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CentraCare Clinic

    Saint Cloud, Minnesota, 56303

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Siouxland Hematology-Oncology

    Sioux City, Iowa, 51101-1733

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105-1080

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

Other trials in United States

Canada1 site

  • Saskatchewan Cancer Agency

    Regina, Saskatchewan, S4S 6X3

Other trials in Canada

About this study

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

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.

Read the 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.

Keywords
unresectable gallbladder cancer, recurrent gallbladder cancer
Medical subject headings
Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00003276
Study groupRoleWhat they receive
irinotecanExperimentalPatients 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.
Receives: Drug: irinotecan hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective tumor response rate

    Measured: Up to 5 years

Secondary outcomes (2)

  1. overall survival

    Measured: Up to 5 years

  2. time to progression

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2004 (estimated)
  2. Study startMar 1998
  3. Primary completionMar 2001
  4. Study completionMar 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003276
Sponsor's protocol ID
NCCTG-964252
Other IDs
CDR0000066181
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Alberts SR, Fishkin PA, Burgart LJ, Cera PJ, Mahoney MR, Morton RF, Johnson PA, Nair S, Goldberg RM; North Central Cancer Treatment Group. CPT-11 for bile-duct and gallbladder carcinoma: a phase II North Central Cancer Treatment Group (NCCTG) study. Int J Gastrointest Cancer. 2002;32(2-3):107-14. doi: 10.1385/ijgc:32:2-3:107.

    PubMed 12794246

  • Fishkin P, Alberts S, Mahoney M, et al.: Irinotecan (CPT-11) in patients (Pts) with advanced gallbladder (GB) Carcinoma (CA): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-618, 2001.

  • Alberts S, Mahoney M, Fishkin P, et al.: Toxicity of irinotecan (CPT-11) in patients (PTS) with advanced gallbladder (GB) or biliary (BILI) tumors: a North Central Cancer Treatment Group (NCCTG) study. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-1166, 2000.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan hydrochloride in people with Gallbladder Cancer, run by Alliance for Clinical Trials in Oncology at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective tumor response rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003276, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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