A Study of Enzastaurin and Erlotinib in Patients With Solid Tumors and Lung Cancer

• Phase 1: Assess the tolerated dose of the combination erlotinib and enzastaurin. [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
• Phase 2: Assess progression free survival with the combination regimen. [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

• Phase I: Assess the tolerated dose of the combination erlotinib and enzastaurin.
• Phase II: Assess progression free survival with the combination regimen. Overall survival time is defined as the time from the date of study enrollment to the date of death from any cause. A responder is defined as any patient who exhibits a confirmed
• complete response or partial response.
• Tumor response rate is defined as the number of responders divided by the number of protocol-qualified patients.

• Phase 1: safety and adverse event profile for enzastaurin/erlotinib combination [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
• Evaluate pharmacokinetic interactions between enzastaurin and erlotinib [ Time Frame: cycle 1 ] [ Designated as safety issue: No ]
• Phase 2: overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
• Phase 2: duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
• Phase 2: tumor response [ Time Frame: baseline to measured tumor response ] [ Designated as safety issue: No ]
• Phase 2: safety and adverse event profile [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Phase I: A study to see what doses of Enzastaurin and Erlotinib are best tolerated by patients with solid tumor cancer.

Phase II: A study to see how long patients with non-small cell lung cancer treated with Enzastaurin and Erlotinib live

• Drug: enzastaurin

  Phase 1: 500 mg oral loading dose day 1, 250 mg oral daily day 2-28, 28 day cycle until disease progression

  Dose Escalation:1125 mg oral loading dose day 1, 500 mg oral daily until disease progression

  Phase 2: phase 1 determined dose, oral, daily, 28 day cycles until disease progression

  Other Name: LY317615
• Drug: erlotinib
  150 mg, oral, daily, 28 day cycles until disease progression

Inclusion Criteria:

1. Phase 1: Any incurable solid malignancy, with no more than 3 prior systemic treatment regimens.

   Phase 2: Histologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV per American Joint Committee on Cancer Staging Criteria for NSCLC. Patients must have failed 1 or 2 prior systemic treatment regimen(s).

2. Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale
3. Prior chemotherapy must be completed at least 2 weeks prior to study enrollment, and the patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
4. Prior radiotherapy is allowed to < 25% of the bone marrow Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
5. Non-measurable or measurable disease as defined by RECIST.

Exclusion Criteria:

Patients who

1. Are unable to swallow tablets.
2. Unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
3. Have previously been treated with an epidermal growth factor receptor (EGFR) inhibitor, including erlotinib.
4. Are receiving concurrent administration of any other antitumor therapy.
5. Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.