Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor

• Status: Completed
• Trial end date: 2011-02-25
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, 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.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given with oxaliplatin and fluorouracil and to see how well they work in treating patients with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other solid tumor.

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

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Fluorouracil; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic or surgically unresectable solid tumor meeting 1 of the following criteria:

• Any solid tumor (Phase I)

• Adenocarcinoma of the stomach or gastroesophageal junction (Phase II)

• Unidimensionally measurable disease by CT scan or MRI

• No uncontrolled brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 8.0 g/dL

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Total bilirubin normal

• Meets 1 of the following criteria:

• Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times ULN

• AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

• AP ≤ 5 times ULN AND AST or ALT normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy

• No preexisting neuropathy

• No concurrent uncontrolled illness or other condition that would preclude study compliance

• No history of severe hypersensitivity reaction to docetaxel or to other drugs formulated with polysorbate 80

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study

PRIOR CONCURRENT THERAPY:

• Recovered from prior therapy

• More than 4 weeks since prior therapy (Phase I)

• No prior oxaliplatin or taxanes (Phase I)

• More than 4 weeks since prior radiotherapy (Phase I)

• No more than two prior therapies for metastatic disease (Phase I)

• No prior therapy for metastatic disease (Phase II)

• At least 6 months since prior adjuvant therapy (given prior to the occurrence of metastatic disease) (Phase II)

• Prior fluorouracil and concurrent radiotherapy for palliation of the primary tumor allowed provided metastatic disease is present outside the radiotherapy field (Phase II)

• No prior radiotherapy to ≥ 30% of bone marrow

• No other concurrent investigational agents