CompletedPhase 1/2

Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer

United States156 participantsStarted 2012-09-28

Plain-language summary

This randomized phase I/II trial studies the side effects and best dose of veliparib when given together with or without cisplatin and etoposide and to see how well they work in treating patients with extensive stage small cell lung cancer or large cell neuroendocrine non-small cell lung cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work better in treating patients with extensive stage small cell lung cancer or metastatic large cell neuroendocrine non-small cell lung cancer.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

PHASE I Inclusion Criteria (phase I): * Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study * All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception * Patients must have histologically or cytologically confirmed: * Extensive stage small cell lung cancer (SCLC) or * Stage IV (M1a or M1b according to American Joint Committee on Cancer \[AJCC\] Staging Manual, 7th edition) large cell neuroendocrine non-small cell lung cancer (NSCLC) or * Small cell carcinoma of unknown primary or extrapulmonary origin and must be a candidate for systemic therapy * NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including…

What they're measuring

Recommended Phase II Dose (Phase I)

Timeframe: assessed for a maximum of cycle 1

Progression Free Survival (Phase II)

Timeframe: Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of first documented progression or death. No specific requirements if patient is > 3 years from registration

Trial details

NCT IDNCT01642251

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2016-12-08

Results submitted2018-09-07

View on ClinicalTrials.gov More Extensive Stage Small Cell Lung Carcinoma trials