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

Sponsor

University of Medicine and Dentistry of New Jersey (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00119314

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma of Unknown Primary	Drug: capecitabine Drug: docetaxel Drug: gemcitabine hydrochloride Procedure: positron emission tomography	Phase 2

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

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

Study Type:

Interventional

Actual Enrollment :

0 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
2	Cancer Center at the Mountainside Hospital	Montclair	New Jersey	United States	07042
3	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
4	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
5	Hematology and Oncology Group	Somerset	New Jersey	United States	08873
6	Overlook Hospital	Summit	New Jersey	United States	07902-0220