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

Sponsoren

Hauptsponsor: Alliance for Clinical Trials in Oncology

Mitarbeiter: National Cancer Institute (NCI)

Quelle Alliance for Clinical Trials in Oncology
Kurze Zusammenfassung

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.

detaillierte Beschreibung

OBJECTIVES:

- Determine the objective tumor response rate in patients with metastatic gastric or gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine.

- Determine the time to progression in patients treated with this regimen.

- Determine the overall survival in patients treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

- Determine whether interleukin-1 polymorphisms are present among patients who have weight loss vs no weight loss, and their relationship to a poor prognosis.

- Assess the quality of life and swallowing uniscale during chemotherapy in these patients.

OUTLINE: 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.

Gesamtstatus Completed
Anfangsdatum September 2003
Fertigstellungstermin February 2008
Primäres Abschlussdatum February 2007
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Proportion of successes Up to 3.5 years
Sekundäres Ergebnis
Messen Zeitfenster
Survival time Up to 3.5 years
Time to disease progression Up to 3.5 years
Duration of response Up to 3.5 years
Time to treatment failure Up to 3.5 years
Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires Up to 3.5 years
Einschreibung 46
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: capecitabine

Armgruppenetikett: docetaxel + capecitabine

Interventionsart: Drug

Interventionsname: docetaxel

Armgruppenetikett: docetaxel + capecitabine

Teilnahmeberechtigung

Kriterien:

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 sorivudine

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Aminah Jatoi, MD Study Chair Mayo Clinic
Ort
Einrichtung:
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas, 67068, United States
Southwest Medical Center | Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton | Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina | Salina, Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review | Wichita, Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas, 67214, United States
CCOP - Wichita | Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas, 67156, United States
Fairview Ridges Hospital | Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital | Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center | St. Louis Park, Minnesota, 55416, United States
United Hospital | St. Paul, Minnesota, 55102, United States
Ridgeview Medical Center | Waconia, Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota, 55125, United States
Standort Länder

United States

Überprüfungsdatum

December 2016

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: docetaxel + capecitabine

Art: Experimental

Beschreibung: 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.

Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov