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Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group

Phase 2
18 Years
Not Enrolling
Carcinoma of Unknown Primary

Thank you

Trial Information

Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group



- Determine the feasibility of positron emission tomography (PET) and pathology
assessment in identifying the primary tumor site in patients with carcinoma of unknown

- Determine the efficacy and safety of gemcitabine, docetaxel, and capecitabine in
patients with carcinoma of unknown primary.


- 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

Inclusion Criteria


- 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

- 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

- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- More than 3 months


- Hemoglobin ≥ 9.0 g/dL

- Granulocyte count > 1,500/mm^3

- Platelet count > 100,000/mm^3


- Bilirubin normal

- Meets 1 of the following criteria:

- Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit normal

- 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


- Creatinine ≤ 1.5 mg/dL


- Able to take oral medication

- Intestinal absorption intact

- No uncontrolled diarrhea and/or daily emesis


- 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


Biologic therapy

- Not specified


- No prior chemotherapy for this malignancy

Endocrine therapy

- Not specified


- 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


- See Disease Characteristics


- No concurrent antiviral therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Elizabeth A. Poplin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

July 2005

Related Keywords:

  • Carcinoma of Unknown Primary
  • newly diagnosed carcinoma of unknown primary
  • recurrent carcinoma of unknown primary
  • Carcinoma
  • Neoplasms, Unknown Primary



Overlook Hospital Summit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Cancer Center at the Mountainside Hospital Montclair, New Jersey  07042
Hematology and Oncology Group Somerset, New Jersey  08873