Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00660140
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : August 13, 2013
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Gallbladder Cancer Drug: Gemcitabine Drug: Carboplatin Phase 2

Detailed Description:

Due to better non-hematologic toxicity profile, less need for pre- and post chemotherapy hydration, and tolerability as compared to cisplatin, we propose to combine gemcitabine with carboplatin in the treatment of patients with cholangiocarcinoma and gallbladder carcinoma. In lung cancer, available literature suggests that carboplatin is as efficacious as cisplatin.

Several Phase I, II and III studies using gemcitabine with carboplatin have already been done or are currently ongoing. Phase I studies determined the maximum tolerated doses (MTD) of gemcitabine at 800-1250 mg/m2 days 1 and 8 combined with at AUC of 4-5.5, day 1 of a 21-day cycle.

Initial Phase II studies using a 28-day schedule using gemcitabine on days 1,8 and 15 with carboplatin caused severe thrombocytopenia on day 15 precluding day 15 treatment in over 50% of courses. A Spanish Lung Cancer Group conducted a sequential Phase II trial wherein 52% and 30% of the first 33 patients with lung cancer treated using the 28-day schedule were noted to have Grade 4 thrombocytopenia and neutropenia, respectively. Subsequently, the next 56 patients were treated on the 21-day schedule, and despite a higher dose intensity, response rates were equal (45-48%) with less Grade 4 thrombocytopenia (21%) but similar rates of Grade 4 neutropenia (27%).

A randomized Italian Phase II studies have demonstrated that when gemcitabine was given at doses of 1 g/m2 with carboplatin at AUC of 5 mg/mL/min were tolerable and when compared to gemcitabine and cisplatin caused less non-hematologic toxicities. Current Phase III trials in lung cancer utilizes the 21-day schedule with gemcitabine at 1000 mg/m2 on days 1 and 8 and carboplatin at AUC of 5.5.

Therefore, our proposed schedule will be gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 with carboplatin dosed at an AUC of 5 on day 1 of a 21-day cycle.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer
Study Start Date : March 2002
Actual Primary Completion Date : January 2007
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: Gemcitabine + Carboplatin

Gemcitabine 1000 mg/m2 IV for 30 minutes on days 1 and 8 of 21 day cycle. Maximum of 9 cycles.

Carboplatin AUC 5 IV for 1 hour on day 1 of 21 day cycle. Maximum of 9 cycles.

Drug: Gemcitabine
Other Name: Gemzar

Drug: Carboplatin
Other Names:
  • Paraplatin
  • Paraplatin-AQ

Primary Outcome Measures :
  1. To determine the response rate and time to failure for patients treated with this regimen [ Time Frame: Every 3 cycles for a maximum of 9 cycles ]
    1 cycle = 21 days

Secondary Outcome Measures :
  1. To describe the toxicities associated with gemcitabine and carboplatin in patients with cholangiocarcinoma or gallbladder cancer. [ Time Frame: 30 days after last dose of study drug ]
  2. To assess the clinical benefit, or lack thereof, of chemotherapy on patient's performance status and weight. [ Time Frame: At the end of study treatment ]
  3. Time to progression [ Time Frame: Every 3 months until progression ]
  4. Survival times [ Time Frame: Every 3 months until patient death ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  1. Patients must have biopsy-proven locally-advanced, metastatic or recurrent adenocarcinoma of the biliary ducts or gallbladder.
  2. Patients must have measurable disease.
  3. Patients must be 18 years or older.
  4. Patients must have a NCI CTC Performance Status of 0-2.
  5. Patients must have a life expectancy of >= 3 months.
  6. Patients must not have any prior chemotherapy for metastatic disease. Prior adjuvant radiation therapy and chemotherapy with 5FU and/or gemcitabine is allowed.
  7. At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
  8. Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ.
  9. Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
  10. Initial Required Laboratory Values:

    • 1. Absolute neutrophil count >= 1,500/mm3, platelet count >= 100,000/mm3, and hemoglobin >= 9 g/dL.
    • 2. Serum creatinine should be <= 2 mg/dL.
    • 3. Serum bilirubin should be <= 3.0 mg/dL (biliary stents allowed).
    • 4. Serum transaminases should be <= 5-fold the institutional upper limits.
  11. Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
  12. Patients must be able to sign an informed consent.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00660140

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Benjamin Tan, M.D. Washington University School of Medicine

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Washington University School of Medicine Identifier: NCT00660140     History of Changes
Other Study ID Numbers: 01-0925
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Washington University School of Medicine:

Additional relevant MeSH terms:
Gallbladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs