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RANDOMIZED STUDY OF PHASE I / II OF TRASTUZUMAB (HERCEPTIN) AND ZD1839 (IRESSA) IN PATIENTS WITH CANCER OF MASSASTASICO ON EXPRESSING HER 2 POSITIVE

RANDOMIZED STUDY OF PHASE I / II OF TRASTUZUMAB (HERCEPTIN) AND ZD1839 (IRESSA) IN PATIENTS WITH CANCER OF MASSASTASICO ON EXPRESSING HER 2 POSITIVE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-075-03
Enrollment
5
Registered
2004-01-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

ARM A Type of group
Herceptin 4 mg / kg IV day 1 only then 2 mg / kg 1 time / week X 3 weeks ZD1839 (IRESSA) 250 mg po / day for 4 weeks. Then evaluation Group name:ARM C Type of group
Herceptin 4mg / kg IV day 1 only then 2mg / Kg IV 1 time / week until progression ZD1839 (IRESSA) 250mg po / day, as determined in Phase I until progression or irreversible or unacceptable toxicity.

Sponsors

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men and women with metastatic cancer with diagnosis histological confirmation of adenocarcinoma overexpressing HER2 / neu who have had or not first line of standard chemotherapy Age> 18 years Women should not be pregnant or nursing. Have a negative pregnancy test within 14 days prior to registration, if pre or perimenopausal.

Exclusion criteria

Exclusion criteria: Minors Pregnant

Design outcomes

Primary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)