Clinical trial · Interventional
Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
A Phase II Study Of Gemcitabine (GEMZAR) And Irinotecan (CPT-11) In Previously Untreated Patients With Measurable Disease With Unknown Primary Carcinoma
NCT00066781CI-TRIAL-00026760completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort I (closed to accrual 11/17/05)
- description
- Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: irinotecan hydrochloride
- type
- EXPERIMENTAL
- label
- Cohort II
- description
- Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: irinotecan hydrochloride
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed carcinoma of undetermined origin, with any of the following light microscopic diagnoses:
* Adenocarcinoma
* Poorly differentiated non-small cell carcinoma
* Poorly differentiated squamous cell carcinoma
* Primary site not revealed by the following diagnostic tests:
* Complete history and physical
* Complete blood count and chemistries
* Chest x-ray and/or CT scan
* Abdominal CT scan
* Directed evaluation of symptomatic areas
* Mammogram in women
* Colonoscopy in patients with liver metastases to exclude a colon primary
* Hematoxylin and eosin (H\&E) staining OR immunostaining if H\&E results are unclear, including all of the following:
* Keratin or epithelial membrane antigen
* S-100 or HMB45
* LCA (CD45)
* Chromogranin or synaptophysin
* Thyroid transcription factor 1
* Measurable disease
* Patients with any of the following conditions are not eligible:
* Neuroendocrine tumors
* Women with axillary node involvement only
* Women with adenocarcinoma of the peritoneum
* Carcinoma involving only 1 site, with resectable tumor at that site
* Squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes
* Men with poorly differentiated mediastinal or retroperitoneal tumor with stains suggestive of germ cell origin or serum tumor markers (AFP/HCG)
* Men with prominent blastic bony metastases or markedly elevated prostate-specific antigen, suggesting prostate origin
* Must be willing to provide blood and tissue samples
* No brain or meningeal involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin must meet 1 of the following criteria:
* Less than or equal to upper limit of normal (ULN) and no UGT1A1 genotyping is required
* Greater than ULN but less than 2 times ULN and UGT1A1 for 6/7 genotype or 7/7 genotype patients
* Alkaline phosphatase no greater than 3 times ULN
* AST no greater than 3 times ULN (5 times ULN if liver metastases are present)
Renal
* Creatinine no greater than 2.0 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years
* No other severe concurrent disease that would make the patient inappropriate for the study in the judgment of the investigator
* No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent biologic agents
* No concurrent filgrastim (G-CSF)
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to more than 25% of the bone marrow
* No concurrent radiotherapy
Surgery
* More than 4 weeks since prior major surgeryReferences
Publications (2)
- RESULTHoltan SG, Foster NR, Erlichman CE, et al.: Gemcitabine (G) and irinotecan (CPT-11) as first-line therapy for carcinoma (ca) of unknown primary (CUP): An NCCTG phase II trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-13525, 2008.
- DERIVEDHoltan SG, Steen PD, Foster NR, Erlichman C, Medeiros F, Ames MM, Safgren SL, Graham DL, Behrens RJ, Goetz MP. Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial. PLoS One. 2012;7(7):e39285. doi: 10.1371/journal.pone.0039285. Epub 2012 Jul 17. PMID 22815703