Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) fo… (NCT04394858) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
United States46 participantsStarted 2021-03-17
Plain-language summary
This phase II trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Poly (adenosine diphosphate \[ADP\]-ribose) polymerases (PARPs) are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, 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. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Documentation of disease
* Histologic documentation: Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma
* Stage: Advanced (metastatic or unresectable primary) disease
* Tumor site: Histologically-proven pheochromocytoma or paraganglioma
* Radiographic evaluation: Radiographic evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in the 12 months prior to registration
* Measurable disease
* Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 1 cm with CT or MRI (or \>= 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung
* Prior treatment with other somatostatin analog, chemotherapy, radiotherapy (including peptide radionuclide receptor therapy \[PRRT\]), or surgery must be completed \>= 28 days prior to registration. Patients must have recovered from any effects of any major surgery prior to registration
* Prior treatment with radiolabeled metaiodobenzylguanidine (MIBG) must be completed \>= 12 weeks prior to registration and lifetime cumulative 131I-MIBG dose must be \< 1000 MBq kg\^-1 (36 mCi kg\^-1)
* Prior treatment with antibiotics must be completed \>= 7 days prior to registration
* No …
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From randomization to the first documentation of disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) or death, assessed up to 5 years