Clinical trial · Interventional
Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction
A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
- 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 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: Phase II trial to study of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel + capecitabine
- description
- Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment. Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.
- interventionNames
- Drug: capecitabine
- Drug: docetaxel
Primary outcomes (1)
- measure
- Proportion of successes
- timeFrame
- Up to 3.5 years
Secondary outcomes (5)
- measure
- Survival time
- timeFrame
- Up to 3.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
* Deemed unresectable and not a candidate for potentially curative treatment (e.g., surgical resection or combined modality therapy)
* At least 4 weeks since prior abdominal exploration with resection (3 weeks without resection)
* No other more conventional forms of therapy available with a reasonable chance of cure or significant palliation
* Measurable disease\*
* The following are not considered measurable disease:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging
* Cystic lesions NOTE: \*Patients having only lesions measuring ≥ 1 cm to \< 2 cm must use spiral CT scan for all tumor assessments.
* No untreated or treated but symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 2.5 times ULN if alkaline phosphatase is less than ULN OR
* Alkaline phosphatase no greater than 4 times ULN if AST less than ULN
Renal
* Creatinine normal
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No New York Heart Association class III or IV heart disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Ability to swallow capecitabine
* No prior anaphylactic reaction to any taxane
* No prior severe reaction to fluoropyrimidine
* No prior poor tolerance to capecitabine
* No known sensitivity or poor tolerance to fluorouracil
* No known dihydropyrimidine dehydrogenase deficiency
* No uncontrolled infection
* No uncontrolled seizure disorder
* No chronic debilitating disease
* No peripheral neuropathy of any etiology greater than grade 1
* No diabetes mellitus
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma or adequately treated noninvasive carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior immunotherapy or biologic therapy for recurrent or metastatic disease
* No concurrent biologic therapy
Chemotherapy
* No prior chemotherapy for recurrent or metastatic disease except for the following:
* Adjuvant chemotherapy after complete resection of the original tumor
* Neoadjuvant chemotherapy followed by surgical resection of the original tumor
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy except for the following:
* Adjuvant radiotherapy after complete resection of the original tumor
* Neoadjuvant radiotherapy followed by surgical resection of the original tumor
* No prior radiotherapy to 25% or more of the bone marrow
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* No prior organ allograft
Other
* No concurrent brivudine or sorivudineReferences
Publications (3)
- BACKGROUNDJatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535. PMID 20126980
- RESULTJatoi A, Nguyen PL, Foster N, Sun D, Stella PJ, Campbell M, Tschetter LK, Dakhil SR, Mailliard JA, Nikcevich DA. Interleukin-1 genetic polymorphisms and their relationship to the cancer anorexia/weight loss syndrome in metastatic gastric and gastroesophageal junction adenocarcinoma. J Support Oncol. 2007 Jan;5(1):41-6. PMID 17265786
- RESULTGiordano KF, Jatoi A, Stella PJ, Foster N, Tschetter LK, Alberts SR, Dakhil SR, Mailliard JA, Flynn PJ, Nikcevich DA; North Central Cancer Treatment Group. Docetaxel and capecitabine in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction: a phase II study from the North Central Cancer Treatment Group. Ann Oncol. 2006 Apr;17(4):652-6. doi: 10.1093/annonc/mdl005. Epub 2006 Feb 23. PMID 16497828