Status:
COMPLETED
Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastric Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * To establish the maximum tolerated dose of docetaxel when administered with oxaliplatin and fluorouracil in patients with metastatic or unresectable solid tumors. (Phase I) * T...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 20 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2011
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00711243
Start Date
April 20 2005
End Date
February 25 2011
Last Update
February 26 2019
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013