Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I Objectives

Primary:

1. The primary objective of this study is to determine the maximum tolerated dose (MTD) of Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated, locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).

Secondary:

1. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination.

Phase II Objectives

Primary:

1. To assess time to cancer progression to D-FOX treatment regimen.

Secondary:

1. To assess response rate to D-FOX treatment regimen.

2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination treatment regimen.

3. Determine overall survival.

4. Perform an exploratory investigation into the effect of D-FOX on phenotypic abnormalities in blood.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Sanofi-Synthelabo
• Treatments: Docetaxel; Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

1. Histologically documented adenocarcinoma of the stomach or Gastroesophageal Junction (GEJ).

2. Age >18 years;

3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;

4. Chemotherapy: No prior chemotherapy is permitted for metastatic disease. Use of prior chemotherapy in the adjuvant and/or neo-adjuvant setting or as part of a radiosensitization is permitted, provided that the minimum time from completion of such treatment to study entry is at least 12 months;

5. Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of bone marrow reserve provided that they have recovered from the acute, toxic effects of radiotherapy prior to registration. A minimum of 14 days must have elapsed since the end of radiotherapy.

6. Previous Surgery: Previous surgery is permitted provided that wound healing has occurred prior to registration. Minimum of 14 days must have elapsed between a major surgery and start of chemotherapy.

7. At least one target lesion >20 mm (or >10 mm on spiral CT-scan). If indicator lesions are in a previously irradiated field, only a clear disease progression of the irradiated lesion or a new lesion in the previously irradiated field will be accepted

8. Adequate baseline bone marrow, hepatic and renal function, defined as follows:

Neutrophils >1.5 * 10*9/L and platelets >100 * 10*9/L; Bilirubin <1.5 * upper limit of the normal range (ULN); aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) <2.5 * ULN; Serum creatinine <1.5 * ULN;

9. Patients must give written informed consent to participate in the study.

10. Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to registration.

Exclusion Criteria:

1. Concurrent anticancer therapy

2. Pregnant or lactating women

3. History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer or malignancy from which the patient has been disease-free for 5 years;

4. Brain metastases

5. Patients with active or uncontrolled infections or with serious illnesses or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV and/or cirrhosis

6. History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.

7. Known hypersensitivity to any of the drugs.