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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in United States

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.

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2005 (estimated)
  2. Study startJul 2004
  3. Primary completionJul 2005
  4. Study completionJul 2005

Why it stopped: slow accrual

Resources

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)
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

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.

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