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Investigator Initiated Trial: Prospective Study of Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors

18 Years
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Trial Information

Investigator Initiated Trial: Prospective Study of Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors

Patients with incurable cancer frequently ask their doctors for an estimate of survival.
Such estimates can assist patients in making decisions about how best to spend their time
and energy. Survival estimates are also required when considering patients with incurable
cancer for experimental treatments. However, such estimates are difficult to make. There
is some data to suggest that a simple clinical measure, the performance status, combined
with a laboratory blood test, the LDH, may assist in making the survival estimate more
realistic. This study is designed to test if this is the case, using patients with
metastatic lung, breast, colorectal, prostate, or pancreatic cancer or patients with cancer
of unknown primary who have exhausted life-prolonging therapy. These patients will be asked
to consent to entering this study. Their performance status will be assessed by the
Karnofsky and WHO scales, they will be asked to have their blood tested for LDH and they and
their doctor will be asked to estimate their survival. After study entry they will be
allowed to receive palliative radiotherapy, surgery or systemic therapy as indicated
including protocol treatment. After study entry, the only other requirement is that the date
of the patients death be reported so that the duration of survival can be compared with the
doctors and patients estimate and correlated with the performance status and LDH.

Inclusion Criteria:

1. All patients must be at least 18 years of age

2. All patients must have documented incurable metastatic cancer

3. All patients must have exhausted any treatments which are known to prolong survival
in their disease, or have elected not to receive further life-prolonging therapy.
Specifically, patients with the following are eligible:

1. Non-small cell lung cancer patients after third systemic therapy

2. Small cell lung cancer patients after second systemic therapy

3. Breast cancer patients after third cytotoxic therapy (does not include hormonal

4. Colorectal cancer patients after second systemic therapy

5. Hormone refractory prostate cancer patients after first cytotoxic therapy

6. Cancer of unknown primary

7. Pancreatic cancer patients after first systemic therapy

4. The use of systemic (chemotherapy, immunotherapy) or local treatments (XRT) for
palliation of symptoms is allowed

5. Patients with a history of previous cancers are allowed

6. Patients with a history of other significant disease (e.g. heart disease, COPD, etc.)
are allowed

7. All patients must sign informed consent

Exclusion Criteria:

1. Patients with acute or chronic leukemia, Hodgkin's disease, or non-Hodgkins lymphoma
are excluded

2. Patients who do not sign informed consent are excluded

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Disease Progression

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Malcolm Purdy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hematology Oncology Associates


United States: Institutional Review Board

Study ID:

INST 0535C



Start Date:

February 2006

Completion Date:

July 2011

Related Keywords:

  • Cancer



New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
University of New Mexico Albuquerque, New Mexico  87131
Hematology Oncology Associates Albuquerque, New Mexico  87106
St. Vincent Regional Medical Center Santa Fe, New Mexico  87505
Radiation Oncology Associates Albuquerque, New Mexico  87111