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

Primary Purpose

Stomach Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

docetaxel and capecitabine

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring advanced gastric cancer, adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Kuopio University HospitalRecruiting
Oulu Univerity HospitalRecruiting
Satakunta District Hospital
University of TampereRecruiting
Department of Oncology and Radiotherapy, turku University HospitalRecruiting
Vaasa Distric HospitalRecruiting

Outcomes

Primary Outcome Measures

To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00669370

First Posted

April 28, 2008

Last Updated

April 29, 2008

Sponsor

University of Turku

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00669370

Brief Title

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

Acronym

GAST-TaxXel

Official Title

Biweekly Docetaxel (Taxotere®)in Combination With Capecitabine (Xeloda®)as First-Line Treatment in Patients With Advanced Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2006 (undefined)

Primary Completion Date

March 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Turku

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms

Keywords

advanced gastric cancer, adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel and capecitabine

Other Intervention Name(s)

Taxotere, Xeloda

Intervention Description

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

Primary Outcome Measure Information:

Title

To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22)

Time Frame

at baseline and on day 1 at every cycle, at the end of study and every 8 week until progress

Secondary Outcome Measure Information:

Title

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

Time Frame

every 3 cycles, at the end of study and every 3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Raija Ristamäki, MD, PhD

Phone

358-2-313-0520

raija.ristamaki@tyks.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Seppo Pyrhönen, professor

Phone

358-2-313-2800

seppo.pyrhonen@tyks.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raija Ristamäki, MD, PhD

Organizational Affiliation

Department of Oncology and Radiotherapy, Turku University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kuopio University Hospital

City

Kuopio

ZIP/Postal Code

70211

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Päivi Auvinen, MD, PhD

Phone

358-17-172-907

paivi.auvinen@kuh.fi

First Name & Middle Initial & Last Name & Degree

Päivi Auvinen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Heli Virsunen, MD

Facility Name

Oulu Univerity Hospital

City

Oulu

ZIP/Postal Code

90029

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raija Kallio, Md, PhD

Phone

358-8-315-2011

raija.kallio@ppshp.fi

First Name & Middle Initial & Last Name & Degree

Raija Kallio, MD, PhD

Facility Name

Satakunta District Hospital

City

Pori

ZIP/Postal Code

22850

Country

Finland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maija-Leena Murashev, MD

Phone

358-2-62771

maija.murashev@satshp.fi

First Name & Middle Initial & Last Name & Degree

Maija-Leena Murashev, MD

Facility Name

University of Tampere

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tapio Salminen, MD

Phone

358-3-311-611

tapio.salminen@pshp.fi

First Name & Middle Initial & Last Name & Degree

Tapio Salminen, MD

Facility Name

Department of Oncology and Radiotherapy, turku University Hospital

City

Turku

ZIP/Postal Code

20521

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raija ristamäki, MD, PhD

Phone

358-2-313-0520

raija.ristamaki@tyks.fi

First Name & Middle Initial & Last Name & Degree

Eija Korkeila, MD

First Name & Middle Initial & Last Name & Degree

Raija Ristamäki, MD, PhD

First Name & Middle Initial & Last Name & Degree

Seppo Pyrhönen, professor

Facility Name

Vaasa Distric Hospital

City

Vaasa

ZIP/Postal Code

65100

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marjatta Mikkola, MD

Phone

358-6-323-2918

marjatta.mikkola@vshp.fi

First Name & Middle Initial & Last Name & Degree

Marjatta Mikkola, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

28424889

Citation

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.

Results Reference

derived

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

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