Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site

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: NCT00148135
Recruitment Status : Terminated (recruitment goals met)
First Posted : September 7, 2005
Last Update Posted : January 10, 2008
Eli Lilly and Company
Information provided by:
University of Michigan Cancer Center

Brief Summary:

This study is for patients with a type of cancer called carcinoma of unknown primary site (CUP), meaning that the site of the body where the tumor has originated is not clear. Currently, carcinoma of unknown primary site (CUP) accounts for about 5% of all newly diagnosed malignancies. The stage of the tumor is such that it is not treatable by surgery. Currently, the standard treatment for such a type of cancer at that stage is chemotherapy. However, the overall prognosis for patients with metastatic CUP remains poor, even if treated with conventional chemotherapy. Through ongoing research at medical centers around the world, doctors are trying to improve on the presently available chemotherapy regimens. The purpose of the investigators' study is similar: it is trying to determine whether a combination of three chemotherapy drugs - carboplatin, gemcitabine, and capecitabine - will improve the treatment of patients with metastatic CUP. The reason the investigators are interested in the above combination of chemotherapy agents is that each one of them is already used in patients with a variety of specific tumors, such as lung cancer, breast cancer, pancreatic cancer, colon cancer, etc.

This research study will help determine whether the combination of carboplatin, gemcitabine and capecitabine can be used and is effective in patients with carcinoma of unknown primary site.

Condition or disease Intervention/treatment Phase
Carcinoma of Unknown Primary Drug: Carboplatin Drug: Gemcitabine Drug: Capecitabine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase II Trial Evaluating the Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site
Study Start Date : May 2001
Actual Primary Completion Date : April 2006
Actual Study Completion Date : October 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic or cytologic diagnosis of carcinoma, with clinical evidence of metastasis and the primary site not clear after the following work-up:

    • Complete history and physical
    • Laboratory evaluation including serum beta-human chorionic gonadotropin (HCG), serum alpha-fetoprotein for undifferentiated or poorly differentiated carcinomas and serum prostate specific antigen (PSA) in men.
    • Directed radiologic evaluation including, at a minimum, computerized tomography (CT) of chest, abdomen and pelvis and bilateral mammography for female patients.
    • Pathologic immunohistochemistry studies of the surgical or biopsy specimen, including studies for estrogen receptor/progesterone receptor and PSA stains when clinically appropriate.
  • Patients must be at least 18 years of age and have a Zubrod performance status 0-2.
  • Adequate organ function, defined as absolute neutrophil count (ANC) > 1500/ul, platelet count of > 100,000/ul, serum creatinine less than or equal to 2.0 mg/dl, serum bilirubin less than or equal to 1.5 mg/dl.
  • Patients must have measurable disease. (Partial response [PR] - at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.)
  • Patients may be previously untreated or have received one chemotherapy regimen provided it did not include carboplatin, gemcitabine or capecitabine.
  • Patients must have no serious intercurrent medical or psychiatric illness that would limit their ability to provide informed consent or receive protocol therapy.
  • Patients must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to the initiation of therapy.

Exclusion Criteria:

  • Patients with previous invasive malignancy within the preceding 5 years are ineligible unless clinicopathologic information regarding the current neoplasm is clearly discordant from prior disease. Patients with non-melanoma skin cancer or in situ cancer of any site are eligible.
  • Patients with brain metastasis are not eligible.
  • No concurrent chemotherapy, biological or radiotherapy is allowed.
  • Pregnant or lactating women are not eligible. Women and men of childbearing potential must agree to use effective contraception throughout the treatment period, and for six months after treatment has been discontinued.
  • The following groups of patients will not be eligible for the study as they represent populations of patients with CUP for whom more specific treatment approaches are available:

    1. Patients presenting with squamous carcinoma isolated to middle and high cervical lymph nodes
    2. Women presenting with isolated axillary lymphadenopathy
    3. Women presenting with predominant peritoneal carcinomatosis
    4. Men < 50 years of age presenting with predominant mediastinal and/or retroperitoneal nodal involvement and biopsy showing undifferentiated or poorly differentiated carcinoma.

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): NCT00148135

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Eli Lilly and Company
Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center Identifier: NCT00148135     History of Changes
Other Study ID Numbers: UMCC 2001-021
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: January 10, 2008
Last Verified: December 2007

Keywords provided by University of Michigan Cancer Center:
Carcinoma of Unknown Primary Site (CUP)

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs