Study: NCT01918306

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~--------------------------------------------------------------------------------

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~--------------------------------------------------------------------------------

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: cisplatin
Description: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~--------------------------------------------------------------------------------

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~--------------------------------------------------------------------------------

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~--------------------------------------------------------------------------------

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: correlative studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: laboratory biomarker analysis
Description: correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: correlative studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: pharmacological study
Description: correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: correlative studies

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI
Description: correlative studies

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI
Description: correlative studies

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI
Description: correlative studies

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI
Description: correlative studies

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI
Description: correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GDC -0941
Description: Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GDC -0941
Description: Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GDC -0941
Description: Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GDC -0941
Description: Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity