Carcinoma of Unknown PrimaryPhase 2NCT00119314
Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin
A Phase 2 study testing capecitabine, docetaxel and gemcitabine hydrochloride in people with Carcinoma of Unknown Primary, run by University of Medicine and Dentistry of New Jersey at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma of Unknown Primary
- What is being tested?
- capecitabine, docetaxel and gemcitabine hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2004to Jul 2005
- 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 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
Cancer Center at the Mountainside Hospital
Montclair, New Jersey, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Hematology and Oncology Group
Somerset, New Jersey, 08873
Overlook Hospital
Summit, New Jersey, 07902-0220
About this study
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
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.
Read the 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.
- Conditions
- Carcinoma of Unknown Primary
- Keywords
- newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
docetaxelDrug
positron emission tomographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startJul 2004
- Primary completionJul 2005
- Study completionJul 2005
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of Unknown PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Elizabeth A. Poplin, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119314
- Sponsor's protocol ID
- CDR0000433512
- Other IDs
- P30CA072720, CINJ-000404, CINJ-4735, CINJ-NJ2203, CINJ-5073
- Status last verified
- Apr 2011
- First submitted
- 12 Jul 2005
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00119314
- Acronym / sponsor ID
- CDR0000433512
- Conditions
- Carcinoma of Unknown Primary
- Keywords
- newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 13 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine | Drug | – |
| docetaxel | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| positron emission tomography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A. Poplin, MD principal investigator
Rutgers Cancer Institute of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine, docetaxel and gemcitabine hydrochloride in people with Carcinoma of Unknown Primary, run by University of Medicine and Dentistry of New Jersey at 6 sites in United States.
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: withdrawn, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 27 May 2015.