Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer (GAST-TaxXel)

University of Turku

Status and phase

Unknown

Phase 2

Conditions

Stomach Neoplasms

Treatments

Drug: docetaxel and capecitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00669370

2005-002484-87

EudraCT no 2005-002484-87

Details and patient eligibility

About

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.

Full description

GAST-TaxXel is an open, phase II, single arm, non-randomized, Finnish multicenter trial. At least 50 subjects will be enrolled.

Primary endpoint:

To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22) in patients with gastric cancer who receive combination treatment with Taxotere and Xeloda.

Secondary endpoint:

To evaluate time to progression (TTP), overall response rate (ORR) and overall survival (OS).

Quality of life: to evaluate that QOL does not deteriorate from baseline. Quality of life is measured using EORTC QLQ-C30 and QLQ-STO22 with physical functioning score as the primary variable.

Efficacy: time to progression, overall response rate, overall survival Time to progression is defined as time elapsed from inclusion to first documented progression or death whatever the reason. Overall response rate is assessed according to the RECIST criteria. Overall survival is defined as time elapsed from inclusion to death.

Safety: clinical and laboratory toxicities or symptomatology will be graded according to NCI-CTC criteria.

Statistical considerations:

The primary variable, physical functioning score measured by the EORTC QLQ-C30 and QLQ-STO22 instrument, will be analyzed using a paired t-test (change from baseline after two treatment cycles). A 95% confidence interval will also be calculated for the primary variable. Median TTP and OS will be estimated using the Kaplan-Meier method. The ORR will be summarized. Safety variables will be summarized descriptively.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)
Consent form signed and dated before inclusion
Able to comply with the scheduled follow-up and with the management of toxicities.

Exclusion criteria

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.
Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
Patients who cannot be regularly followed up for psychological, social, family or geographic reasons.