Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer
GAST-TaxXel
Biweekly Docetaxel (Taxotere®)in Combination With Capecitabine (Xeloda®)as First-Line Treatment in Patients With Advanced Gastric Cancer
2 other identifiers
interventional
50
1 country
6
Brief Summary
To determine the quality of life in patients with gastric cancer who receive combination treatment with docetaxel and capecitabine. Secondary endpoints are time to progression, overall response rate and overall survival. Study treatment will continue until disease progression or unacceptable toxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedApril 30, 2008
April 1, 2008
2.8 years
April 28, 2008
April 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22)
at baseline and on day 1 at every cycle, at the end of study and every 8 week until progress
Secondary Outcomes (1)
To evaluate time to progression (TTP), overall response rate (ORR) and overall survival (OS).
every 3 cycles, at the end of study and every 3 month
Interventions
biweekly docetaxel iv (50 mg/m2) on day 1 and 15 and capecitabine po 1250 mg/m2 x 2/day days 1-7 and 15-21, treatment cycle consisting of 21 days
Eligibility Criteria
You may qualify if:
- Histologically confirmed advanced, inoperable gastric adenocarcinoma
- age ≥18 years
- WHO performance status ≤ 2
- Stage IV
- Measurable (according to RECIST criteria) or evaluable lesion
- No previous chemotherapy, except adjuvant chemotherapy ≥ 6 months ago
- Adequate hematological function (neutrophils ≥ 1.5 x 109/l and platelets ≥ 100 x 109/l, Hb ≥ 100 g/l (after transfusion when needed)
- Adequate renal function (serum creatinine ≤ 1.25 x upper normal limit)
- Adequate liver function (total serum bilirubin ≤ 1.25 x upper normal limit or ALAT ≤ 3 x upper normal limit; in case of liver metastasis: total serum bilirubin ≤ 1.5 x upper normal limit, ALAT ≤ 5 x upper normal limit)
- AFOS ≤ 2.5 x upper normal limit (unless bone metastases)
- Able to comply with the scheduled follow-up and with the management of toxicities.
You may not qualify if:
- Pregnant or lactating women (or potentially fertile women not using adequate contraception)
- Presence of CNS metastases
- Unresolved bowel obstruction or subobstruction
- Chronic diarrhea
- Clinically significant malabsorption syndrome
- Inability to swallow tablets
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Concurrent severe and/or uncontrolled co-morbid medical condition such as uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction within previous 6 months, congestive heart failure
- History of previous or concurrent malignancy within the previous 5 years except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
- History of prior serious allergic reactions such as anaphylactic shock.
- Peripheral neuropathy ≥ grade 2, unless related to mechanical etiology
- Concurrent use of corticosteroids unless chronic treatment (i.e. initiated \> 6 months prior to study entry) at low doses (≥ 20 mg methylprednisolone or equivalent)
- History of allergy to drugs containing the excipient TWEEN 80® and/ or 5- fluorouracil.
- Lack of physical integrity of the upper gastrointestinal tract.
- Concomitant administration of any other experimental drug under investigation: concurrent treatment with any other anti-cancer therapy.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Turkulead
- Sanoficollaborator
Study Sites (6)
Kuopio University Hospital
Kuopio, 70211, Finland
Oulu Univerity Hospital
Oulu, 90029, Finland
Satakunta District Hospital
Pori, 22850, Finland
University of Tampere
Tampere, 33520, Finland
Department of Oncology and Radiotherapy, turku University Hospital
Turku, 20521, Finland
Vaasa Distric Hospital
Vaasa, 65100, Finland
Related Publications (1)
Korkeila EA, Salminen T, Kallio R, Mikkola M, Auvinen P, Pyrhonen S, Ristamaki R. Quality of life with biweekly docetaxel and capecitabine in advanced gastro-oesophageal cancer. Support Care Cancer. 2017 Sep;25(9):2771-2777. doi: 10.1007/s00520-017-3689-5. Epub 2017 Apr 20.
PMID: 28424889DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raija Ristamäki, MD, PhD
Department of Oncology and Radiotherapy, Turku University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2008
First Posted
April 30, 2008
Study Start
June 1, 2006
Primary Completion
March 1, 2009
Last Updated
April 30, 2008
Record last verified: 2008-04