Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors

This is an observational trial for Breast Cancer focused on measuring thromboembolism, recurrent breast cancer, stage IV breast cancer, recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent gastric cancer, stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent small cell lung cancer, recurrent ovarian epithelial cancer, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage I ovarian germ cell tumor, stage II ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, stage IIB prostate cancer, stage IIA prostate cancer, male breast cancer Read More

DISEASE CHARACTERISTICS:

• Cytologically or histologically confirmed diagnosis of 1 of the following:

  • Metastatic breast cancer
  • Colorectal cancer
  • Gastric cancer
  • Lung cancer
  • Ovarian cancer
  • Pancreatic cancer
  • Hormone-refractory prostate cancer

• Scheduled to undergo chemotherapy for ≥ 3 months

  • Chemotherapy for colorectal, gastric, lung, ovarian, or pancreatic cancer may be administered in the neoadjuvant, adjuvant, or palliative setting

• History of deep vein thrombosis or pulmonary embolism allowed if treatment and secondary prevention of the last episode was completed prior to study entry

  • Negative baseline bilateral compression ultrasonography

PATIENT CHARACTERISTICS:

• Life expectancy > 3 months

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 6 weeks since prior chemotherapy*

  • Hormonal therapy alone is not considered chemotherapy

• More than 4 weeks since prior major surgery, including surgery for cancer

  • Minor surgery (e.g., implant of a port-a-cath) within the past 4 weeks allowed
• No concurrent major surgery, including surgery for cancer, during the observation period
• Radiotherapy before or during the observation period allowed
• Concurrent chemotherapy* in combination with additional hormonal therapy allowed
• Concurrent treatment (with the exception of antithrombotic therapy) in any other clinical trial allowed

• No concurrent or scheduled use of thromboprophylaxis or any anticoagulant therapy, including any of the following:

  • Parenteral anticoagulants (e.g., heparin, low molecular-weight heparin, or other agents, such as fondaparinux or bivalirudin)
  • Oral anticoagulants (e.g., vitamin K antagonists)

  • Thrombolytic agents

    • Chronic treatment with antiplatelet agents, such as low-dose aspirin (≤ 300 mg/day) or clopidogrel allowed NOTE: *Chemotherapy is defined as treatment with any antineoplastic agent, including biologicals