Table 1.

Number of prior cytotoxic therapies and prior radiation history for patients enrolled in the solid tumor cohort (n = 30)

Dose levelHistology/tumor typeNo. prior cytotoxic therapiesPrior radiation therapy historyNo. cycles of study treatment
1Invasive ductal carcinoma-breast3Breast, supraclavicular fossa, whole brain radiation4
1Head and neck carcinoma3Mandible, neck, parapharyngeal space20
1Neuroendocrine carcinoma of the vulva3Left labia majora1
2Soft-tissue sarcoma of the thigh-pleomorphic liposarcoma2Left thigh1
2Non-small cell lung cancer1None3
2Non-small cell lung cancer1None14
2Renal cell carcinoma-clear cell3Whole-brain radiation2
2Colon cancer5Hip and femur3
2Colon cancer3None2
2Head and neck, squamous cell carcinoma2Thoracic spine (T3-T7)16
2*Nasopharyngeal carcinoma2Nasopharynx, supraclavicular lymph nodes, posterior neck8
2*Nasopharyngeal carcinoma1Nasopharynx20
2*Rectal cancer-squamous cell carcinoma2Right pubic ramus1
2*Atypical carcinoid arising from the trachea2Neck4
2*Head and neck, squamous cell carcinoma1Larynx and lymph nodes3
2*Nasopharyngeal carcinoma1Nasopharynx, supraclavicular lymph nodes, posterior neck16
2*Head and neck, squamous cell carcinoma2Breast, oral cavity, neck4
2*Nasopharyngeal carcinoma2Nasopharynx, supraclavicular lymph nodes, posterior neck3
3Non-small cell lung cancer1None6
3Non-small cell lung cancer1None15
3Head and neck, squamous cell carcinoma2None8
4Head and neck, squamous cell carcinoma1Head and neck radiation4
4Head and neck, squamous cell carcinoma2Head and neck radiation4
4Head and neck, squamous cell carcinoma1Head and neck radiation12
3Thyroid cancer1Thyroid/neck radiation11
3Carcinosarcoma of the ovary2None2
3Endometrial adenocarcinoma1None7
3Uterine carcinosarcoma1None8
3Endometrial adenocarcinoma2None2
3Non-small cell lung cancer3None8
  • * After DLT was observed at dose level 2, the protocol eligibility criteria were amended to permit solid tumor patients with no more than two prior cytotoxic treatments and no history of whole brain radiation, and dose level 2 was repeated with patients meeting these stricter eligibility criteria.