Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Capecitabine

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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

docetaxel and capecitabine

Raija Ristamäki, MD, PhD

Seppo Pyrhönen, professor

Päivi Auvinen, MD, PhD

Heli Virsunen, MD

Raija Kallio, Md, PhD

Raija Kallio, MD, PhD

Maija-Leena Murashev, MD

Tapio Salminen, MD

Raija ristamäki, MD, PhD

Eija Korkeila, MD

Marjatta Mikkola, MD

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.

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.

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

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

Sanofi

University of Turku

Raija Ristamäki

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

John M Waples, MD

In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.

Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

Oncology Specialties, Alabama

Carcinoma, Lobular

Carcinoma, Ductal, Breast

Bone Density Conservation Agents

Tamoxifen

Letrozole

Estrogens

Progesterone

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

* FEC 100
* Canadian CEF
* CAF
* FAC
* E-CMF

2 years of tamoxifen followed by 5 years of letrozole

chemotherapy-decision-making according to clinical criteria (using Adjuvant! Online)

chemotherapy-decision-making according to genomic prognosis using the 70-gene signature

anthracycline-based

tamoxifen

Emiel Rutgers, MD, PhD

Martine Piccart-Gebhart, MD, PhD

Fatima Cardoso, MD

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving chemotherapy and hormone therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether genetic testing is more effective than clinical assessment in determining the need for chemotherapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying genetic testing to see how well it works compared with clinical assessment in determining the need for chemotherapy in women with breast cancer that is either node-negative or involves no more than 3 lymph nodes.

OBJECTIVES:

Primary

* Compare a molecular profiling approach (70-gene signature) vs usual clinical assessment in assigning adequate risk categories (and the need to receive adjuvant chemotherapy or not) to breast cancer patients with 0-3 positive lymph nodes.
* Compare the efficacy and long-term toxicities of docetaxel and capecitabine vs standard anthracycline-based chemotherapy regimens in these patients.
* Determine the best endocrine treatment strategy (i.e., letrozole for 7 years vs sequential tamoxifen for 2 years followed by letrozole for 5 years) in these patients.

Secondary

* Compare both relative (hazard ratio) and absolute (percentage at 5 years) efficacy of these regimens, in terms of disease-free survival (DFS), distant metastasis-free survival (DMFS), and overall survival (OS), in these patients.
* Determine overall estimates of efficacy (DFS, DMFS, OS) for each treatment strategy according to clinical-pathological prognosis and molecular prognosis in these patients.
* Estimate the percentage of patients receiving chemotherapy per each prognostic method.
* Identify predictive gene expression profiles of clinical response/resistance to anthracycline-based and docetaxel-capecitabine chemotherapy in these patients.
* Compare novel gene expression signatures predicting clinical response in patients treated with sequential tamoxifen-letrozole vs letrozole alone.
* Compare the OS distributions in patients treated with these regimens.
* Compare the early and late toxicities of these regimens in these patients.
* Evaluate adjuvant endocrine treatment success or failure in the subgroup of postmenopausal patients with endocrine-responsive disease.
* Compare the safety profile of these two endocrine therapy regimens in these patients.

OUTLINE: This is a partially randomized, open-label, prospective, multicenter study.

Patients with both clinical high-risk (CHR) and genomic high-risk (GHR) disease are assigned to receive chemotherapy. Patients with both clinical low-risk (CLR) and genomic low-risk (GLR) disease do not receive chemotherapy. Patients with discordant risk between the 2 decision-making tools (standard clinical-pathological criteria vs 70-gene signature criteria) are randomized to receive chemotherapy or not. Patients with HER-2 positive tumors which have both methods discordant and were randomized to no chemotherapy, can receive adjuvant trastuzumab alone or with adjuvant endocrine therapy (if hormonal receptor positive), if decided by the treating physician. Patients with HER-2 positive tumors that are classified low-risk by both methods can receive adjuvant trastuzumab alone or with adjuvant endocrine therapy (if hormonal receptor positive), if decided by the treating physician and if no issues for trastuzumab reimbursement exist in the investigator's country.

* Chemotherapy: Patients are stratified according to participating center, risk group (GHR/CLR vs GLR/CHR), hormone receptor status (estrogen receptor \[ER\] positive and/or progesterone receptor \[PR\] positive vs ER and PR negative), age (\< 50 years vs at least 50 years), HER2/neu status (positive vs negative vs unknown), method of axillary evaluation (sentinel only vs dissection), and type of surgery (mastectomy vs quadrantectomy/tumorectomy). In case PR is unknown, the patient will be stratified to the hormone receptor (HR) negative group if ER is negative, and to the HR positive group if ER is positive.

Three randomizations took place:

* One randomization on the discordant groups (where clinical risk did not match genomic risk) in treatment decision (R-T).
* One randomization for patients who are candidates for chemotherapy (R-C): randomization between anthracycline based chemotherapy and taxane/capecitabine chemotherapy.
* One randomization for patients who are candidates for endocrine therapy (R-E): randomization between 2 years of tamoxifen followed by 5 years of letrozole and 7 years of letrozole.

For the treatment decision randomization, patients for whom both methods are discordant will be randomized (R-T) between chemotherapy-decision-making according to clinical criteria (using Adjuvant! Online) or chemotherapy-decision-making according to genomic prognosis using the 70-gene signature.

For the chemotherapy randomization, patients are randomized to 1 of 2 treatment arms.

* Arm I (anthracycline-based): Patients may receive 1 of the following regimens\*:

  * FEC 100: Patients receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses.
  * Canadian CEF: Patients receive oral cyclophosphamide on days 1-14 (or IV on days 1 and 8) and epirubicin hydrochloride IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses.
  * CAF: Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV, and fluorouracil IV on day 1. Treatment repeats every 4 weeks for 6 courses.
  * FAC: Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1 and fluorouracil IV on days 1 and 8. Treatment repeats every 3 weeks for 6 courses.
  * E-CMF: Patients receive epirubicin hydrochloride IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 4 courses.

NOTE: \*Patients who refuse randomization may be treated with another chemotherapy regimen and still be included in the study.

* Arm II (docetaxel and capecitabine): Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 6 courses.

For the endocrine therapy randomization (all postmenopausal and some premenopausal\*\* patients who have endocrine-responsive tumors\*\*\*): Patients are stratified according to participating center, risk group (GHR/CHR vs GHR/CLR vs GLR/CHR vs GLR/CLR), adjuvant chemotherapy (no vs nonrandomized vs arm I vs arm II), endocrine sensitivity (both ER and PR positive vs either ER or PR positive), age (\< 50 years vs at least 50 years), HER2/neu status (positive vs negative vs unknown), method of axillary evaluation (sentinel only vs dissection), and type of surgery (mastectomy vs quadrantectomy/tumorectomy). In case PR is unknown, the patient will be stratified to the HR negative group if ER is negative, and to the HR positive group if ER is positive.

Therapy begins after prior surgery in patients who did not receive chemotherapy and after chemotherapy in those who did. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral tamoxifen citrate once daily for 2 years. Patients then receive oral letrozole once daily for 5 years.
* Arm II: Patients receive oral letrozole once daily for 7 years. NOTE: \*The first dose of endocrine therapy should be administered within 4 weeks following the randomization (R-E) date. If treatment has not started within 300 days after definitive surgery, the patient becomes ineligible for randomized endocrine therapy.

NOTE: \*\*Premenopausal women (\< 50 years) must undergo adequate ovarian suppression (gonadotropin releasing hormone, bilateral oophorectomy, or bilateral ovarian radiation).

NOTE: \*\*\*Patients who have endocrine-responsive tumors but refuse randomization should receive standard endocrine therapy and may remain on study.

After completion of study treatment, patients are followed annually for at least 15 years.

FINAL ACCRUAL: A total of 6,694 patients have been accrued for this study.

Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes

MINDACT (Microarray In Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy): A Prospective, Randomized Study Comparing the 70-Gene Signature With the Common Clinical-Pathological Criteria in Selecting Patients for Adjuvant Chemotherapy in Breast Cancer With 0 to 3 Positive Nodes

o The primary endpoint for chemotherapy versus no chemotherapy (R-T) is that the 5-year distant metastasis free survival (DMFS) of 92% will be tested (a one-sided test).

o The primary endpoint for the chemotherapy randomization (R-C) is disease free survival (DFS).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer	NCT00669370	Stomach Neoplas...	docetaxel and c...	18 Years -	University of Turku
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma	NCT00225056	Metastatic Brea...	docetaxel and c...	19 Years - 85 Years	Oncology Specialties, Alabama
Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes	NCT00433589	Breast Cancer	anthracycline-b... docetaxel and c... tamoxifen Letrozole	18 Years - 120 Years	European Organisation for Research and Treatment of Cancer - EORTC
Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer	NCT00669370	Stomach Neoplas...	docetaxel and c...	18 Years -	University of Turku
Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes	NCT00433589	Breast Cancer	anthracycline-b... docetaxel and c... tamoxifen Letrozole	18 Years - 120 Years	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for docetaxel and capecitabine