Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary (NCT00357630) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary
United States52 participantsStarted 2006-06
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with metastatic cancer of unknown primary.
Who can participate
Age range
18 Years – 120 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 confirmed poorly differentiated carcinoma or adenocarcinoma of unknown primary
* Diagnosis based on biopsy and conventional imaging, including CT scans of the chest, abdomen, and pelvis with or without positron emission tomography (PET) scans or other specialized tests, performed within the past 4 weeks
* Must not have any of the following clinical features:
* Squamous cell carcinoma in the lymph nodes of the neck or inguinal nodes only
* Women with axillary lymph node metastases only
* Women with peritoneal carcinomatosis only
* Well-differentiated neuroendocrine tumors
* Poorly differentiated tumors with midline tumor or elevated human chorionic gonadotropin (HCG)/alpha-fetoprotein (AFP)
* Men with adenocarcinoma and elevated prostate-specific antigen (PSA)
* Measurable disease
* No symptom emergency at the time of study entry including, but not limited to, the following:
* Back pain with epidural cord compression
* Large effusions causing distress
* Hypercalcemia
* Bowel obstruction
* Very painful (worst pain 10/10) solitary bone metastases with impending fracture
PATIENT CHARACTERISTICS:
* Modified "Physical Well-Being" subscale of the FACT-G score ≥ 6 within the past week
* Pain-intensity score ≥ 20 mm on the Memorial Pain Assessment Card OR receiving analgesics of ≥ 10 mg per day of oral morphine equivalent within the past week
* ECOG performance status 1-2
* WBC ≥ 3,000/mm³
* Platelet count ≥ 100,0…
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.
What they're measuring
1
Efficacy, in terms of improved quality of life and reduction of symptom distress