CompletedPhase 1

Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer

United States24 participantsStarted 2000-06

Plain-language summary

Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced or metastatic adenocarcinoma * Expression of +1 to 3+ HER2/neu on immunohistochemical or immunocytochemistry staining * No brain metastases unless all of the following is true: * Previously treated * Asymptomatic * Stable dose of decadron * No evidence of edema PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-2 * Life expectancy: At least 12 weeks * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL * Bilirubin no greater than 1.5 mg/dL * AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver involvement) * Creatinine no greater than 1.5 mg/dL * LVEF at least 50% by RVG or MUGA * No uncontrolled unstable angina * No history of congestive heart failure or cardiac ischemia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent active infection or serious systemic disorder that would preclude study * No allergies to imidazole compounds PRIOR CONCURRENT THERAPY: * No prior trastuzumab (Herceptin) No other concurrent immunotherapy * At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent hormonal cancer therapy except LHRH agonists for prostate cancer * No concurrent radiotherapy * No other concurrent…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00005842

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2004-02

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