Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer

Conditions

• Extensive Stage Lung Small Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Cediranib — DRUG
  Given PO
• Cediranib Maleate — DRUG
  Given PO
• Cisplatin — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Olaparib — DRUG
  Given PO

Study Details

This phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, such as carboplatin, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate, and standard chemotherapy may work better in treating patients with small cell lung cancer.

Key Dates

Start date

Mar 30, 2018

Status verified

Sep 2023

Primary completion

Mar 17, 2020

Completion

Mar 17, 2020

Study Design

Enrollment

9 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (chemotherapy, cediranib maleate, olaparib)
  Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive maintenance therapy or no maintenance therapy. Patients in Arm II are assigned to receive maintenance therapy. MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. NO MAINTENANCE THERAPY: Patients are eligible to crossover to receive treatment with cediranib maleate and olaparib upon disease progression at the treating investigator's discretion.
• Experimental: Arm II (chemotherapy, cediranib maleate, olaparib)
  Patients receive treatment as in Arm I and also receive cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28.

Primary Outcome Measure

Median Progression-free Survival in Patients Who Receive Cediranib Maleate/Olaparib as Maintenance Therapy [ Time Frame: From second randomization to documented disease progression or death from any cause, whichever occurs first, assessed up to 6 months ]

Locations (24)

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