Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turku
• Collaborator: Sanofi
• Treatments: Capecitabine; Docetaxel

Criteria

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.