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

This study has been terminated.
(recruitment goals met)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00148135
First received: September 2, 2005
Last updated: December 28, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Carcinoma of Unknown Primary
Drug: Carboplatin
Drug: Gemcitabine
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase II Trial Evaluating the Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Study Start Date: May 2001
Study Completion Date: October 2007
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148135

Locations
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
Investigators
Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00148135     History of Changes
Other Study ID Numbers: UMCC 2001-021
Study First Received: September 2, 2005
Last Updated: December 28, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Gemcitabine
Capecitabine
Fluorouracil
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 26, 2014