Clinical trial · Interventional
Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin
Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of Unknown Primary | Carcinoma of Unknown Primary | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| positron emission tomography | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
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