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Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin

Primary Purpose

Carcinoma of Unknown Primary

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
docetaxel
gemcitabine hydrochloride
positron emission tomography
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignancy for which no primary origin has been identified despite routine workup, including the following: History and physical examination Chemistry profile and other blood work, including tumor markers with follow up on any positive findings CT scan or MRI of the chest, abdomen, and pelvis Mammography (for female patients) Prostate examination (for male patients) Stool guaiac Measurable disease Previously irradiated lesions are not considered measurable disease unless there is documented clear tumor progression in these lesions after completion of radiotherapy The following tumor types or presentations are excluded: Resectable disease Tumors consistent with germ cell primary, as indicated by any of the following: Midline tumor Elevated beta human chorionic gonadotropin Elevated alpha-fetoprotein i12p chromosomal alteration Prostate primary with elevated prostate-specific antigen Females with axillary nodes as the primary disease site Tumors limited to the peritoneal cavity consistent with primary peritoneal carcinoma Neuroendocrine tumors Squamous cell carcinoma involving cervical or inguinal lymph nodes No symptomatic brain metastases Prior brain metastases allowed provided patient completed definitive treatment with brain irradiation with or without resection PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic Hemoglobin ≥ 9.0 g/dL Granulocyte count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic Bilirubin normal Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit normal (ULN) AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST and ALT normal Albumin ≥ 3.0 g/dL Renal Creatinine ≤ 1.5 mg/dL Gastrointestinal Able to take oral medication Intestinal absorption intact No uncontrolled diarrhea and/or daily emesis Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer No severe medical or psychiatric illness that would preclude study treatment No peripheral neuropathy > grade 1 No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for this malignancy Endocrine therapy Not specified Radiotherapy See Disease Characteristics Recovered from prior radiotherapy Prior palliative radiotherapy to areas of bony metastases allowed provided there is measurable disease outside the radiotherapy port At least 4 weeks since prior radiotherapy No prior radiotherapy to ≥ 25% of the bone marrow Surgery See Disease Characteristics Other No concurrent antiviral therapy

Sites / Locations

  • Cancer Institute of New Jersey at Hamilton
  • Cancer Center at the Mountainside Hospital
  • Carol G. Simon Cancer Center at Morristown Memorial Hospital
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Hematology and Oncology Group
  • Overlook Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 12, 2005
Last Updated
May 22, 2015
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00119314
Brief Title
Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin
Official Title
Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Withdrawn
Why Stopped
slow accrual
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel and capecitabine works in treating patients with cancer of unknown primary origin.
Detailed Description
OBJECTIVES: Primary Determine the feasibility of positron emission tomography (PET) and pathology assessment in identifying the primary tumor site in patients with carcinoma of unknown primary. Determine the efficacy and safety of gemcitabine, docetaxel, and capecitabine in patients with carcinoma of unknown primary. Secondary Determine the frequency with which PET scan and pathology assessment can define the organ of origin in these patients. OUTLINE: This is a 2-part, multicenter study. Part 1: Patients undergo a comprehensive standard evaluation, including pathologic assessment and positron emission tomography scan, to attempt to identify the primary tumor site. If the primary tumor site is identified, the patient proceeds to appropriate treatment for that tumor off study. If the primary tumor site remains unknown, the patient proceeds to chemotherapy in part 2 of the study. Part 2: Patients receive gemcitabine IV and docetaxel IV over 30 minutes on days 4 and 11. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 4 weeks and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 44 patients (10-29 for part 2) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Unknown Primary
Keywords
newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignancy for which no primary origin has been identified despite routine workup, including the following: History and physical examination Chemistry profile and other blood work, including tumor markers with follow up on any positive findings CT scan or MRI of the chest, abdomen, and pelvis Mammography (for female patients) Prostate examination (for male patients) Stool guaiac Measurable disease Previously irradiated lesions are not considered measurable disease unless there is documented clear tumor progression in these lesions after completion of radiotherapy The following tumor types or presentations are excluded: Resectable disease Tumors consistent with germ cell primary, as indicated by any of the following: Midline tumor Elevated beta human chorionic gonadotropin Elevated alpha-fetoprotein i12p chromosomal alteration Prostate primary with elevated prostate-specific antigen Females with axillary nodes as the primary disease site Tumors limited to the peritoneal cavity consistent with primary peritoneal carcinoma Neuroendocrine tumors Squamous cell carcinoma involving cervical or inguinal lymph nodes No symptomatic brain metastases Prior brain metastases allowed provided patient completed definitive treatment with brain irradiation with or without resection PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic Hemoglobin ≥ 9.0 g/dL Granulocyte count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic Bilirubin normal Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit normal (ULN) AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST and ALT normal Albumin ≥ 3.0 g/dL Renal Creatinine ≤ 1.5 mg/dL Gastrointestinal Able to take oral medication Intestinal absorption intact No uncontrolled diarrhea and/or daily emesis Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer No severe medical or psychiatric illness that would preclude study treatment No peripheral neuropathy > grade 1 No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for this malignancy Endocrine therapy Not specified Radiotherapy See Disease Characteristics Recovered from prior radiotherapy Prior palliative radiotherapy to areas of bony metastases allowed provided there is measurable disease outside the radiotherapy port At least 4 weeks since prior radiotherapy No prior radiotherapy to ≥ 25% of the bone marrow Surgery See Disease Characteristics Other No concurrent antiviral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Poplin, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Cancer Center at the Mountainside Hospital
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
Facility Name
Carol G. Simon Cancer Center at Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Hematology and Oncology Group
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902-0220
Country
United States

12. IPD Sharing Statement

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Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin

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