NCT00003558

Brief Summary

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. It is not yet known which combination chemotherapy regimen is more effective for cancer of unknown primary origin. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating patients with cancer of unknown primary origin.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

August 7, 2013

Status Verified

February 1, 2003

First QC Date

November 1, 1999

Last Update Submit

August 6, 2013

Conditions

Carcinoma of Unknown Primary

Keywords

adenocarcinoma of unknown primarynewly diagnosed carcinoma of unknown primary

Interventions

carboplatinDRUG
etoposideDRUG
fluorouracilDRUG
leucovorin calciumDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of any differentiation grade * Excludes the following "treatable" conditions: * Axillary node involvement * Peritonitis carcinomatosis * Blastic bone metastases and/or elevated PSA * Squamous cell cancer with cervical or inguinal presentation * Poorly differentiated carcinoma * Neuroendocrine tumors OR * Tumors located in the mediastinum, retroperitoneum, or nodes * At least one measurable metastatic site * No brain or meningeal metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Hematopoietic: * Leukocyte count at least 4,000/mm3 * Thrombocyte count at least 100,000/mm3 Hepatic: * Bilirubin less than 1.4 mg/dL * AST and ALT less than 3 times upper limit of normal * No cirrhosis of the liver Renal: * Creatinine less than 1.7 mg/dL Cardiovascular: * At least 3 months since myocardial infarction * No congestive heart failure, tachydysrhythmia, or unstable angina pectoris Other: * Not pregnant or nursing * Negative pregnancy test * No active infection * No other serious illness or medical condition * No current or prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy (no greater than 25% of bone marrow) Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

CarboplatinEtoposideFluorouracilLeucovorinPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • R. L. Jansen, MD, PhD

    Academisch Ziekenhuis Maastricht

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

August 1, 1998

Last Updated

August 7, 2013

Record last verified: 2003-02

Locations

NL(2)