January 2012: Trials in Progress

The Trials in Progress section is intended to stimulate discussion about ongoing clinical trials and to promote collaboration across the oncology community. Each month, OBTN will present summaries of ongoing research in a broad range of cancer types.

Gastrointestinal Cancer

Investigating relationship between plasma platinum levels and neurotoxicity in GI cancer patients receiving oxaliplatin therapy

French researchers are recruiting for a phase IV toxicity study in patients with gastrointestinal (GI) cancer who are taking oxaliplatin. Patients who are receiving or plan to receive oxaliplatin will be eligible for enrollment in this multicenter, open-label trial. Patients must have no pre-existing neuropathy, central nervous system disease, or cerebral metastases when enrolled. During the study, the patient’s neurological function and plasma levels will be measured at baseline after each treatment with oxaliplatin (2-hr IV infusions every 2-3 wk), and at the end of study treatment. The primary endpoint is to determine the relationship between plasma levels of residual platinum with persistent neurotoxicity in the hope that this information will help clinicians plan treatment and improve the quality of life of these patients. The secondary endpoint is to determine the pharmacokinetics of oxaliplatin in patients with GI cancer. The estimated enrollment is 58 patients.

Sponsor: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

ClinicalTrials.gov Identifier: NCT00274885

Head and Neck Cancer

Using lyophilized black raspberries to prevent oral cancer

Ohio State University researchers are trying to determine the best method to administer lyophilized black raspberries as prophylaxis to patients who are at high-risk for oral cancer. The use of lyophilized black raspberries may prevent oral cancer in those with previously diagnosed stage I-IV or in situ head and neck cancer. In this phase I/II trial, there will be 2 treatment arms and 2 placebo arms. Patients will be randomized to (1) placebo lozenge or lyophilized raspberry lozenge; or (2) saliva substitute placebo or lyophilized black raspberry saliva substitute. Treatment will continue for 6 months. Primary objectives are to define safety and tolerability of long-term black raspberry administration after surgery in patients with head and neck cancer, to determine the best dose and delivery vehicle, and to correlate gene expression changes within regulatory pathways and dose and delivery method. The estimated enrollment is 140 patients.

Sponsor: Ohio State University Comprehensive Cancer Center, National Cancer Institute

ClinicalTrials.gov Identifier: NCT01469429

Hematologic Cancer

Fludarabine and busulfan with or without clofarabine for AML and MDS patients that need stem cell transplant

Researchers at MD Anderson Cancer Center are actively recruiting for a new phase III study of 2 combination therapies in patients aged 3 to 70 years with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who also must undergo stem cell transplantation. AML patients in any stage and cytogenetic risk group who have not achieved complete remission with 1 course of induction therapy, and MDS patients with intermediate or high-risk IPSS score or treatmentrelated MDS are eligible for the trial. Some other low-risk MDS patients might be eligible. In this open-labeled trial, patients will be randomized to 1 of 2 arms. Arm 1 will receive busulfan, fludarabine, and clofarabine before stem cell transplantation. Arm 2 will receive busulfan and fludarabine before stem cell transplantation. Patients in both arms will also receive treatment to prevent graft-versushost disease. Patients will be followed quarterly for 5 years after treatment. The primary endpoint is progression-free survival, and the secondary endpoint is overall survival. The researchers will also review safety data of this combination therapy. The estimated enrollment is 250 patients.

Sponsor: MD Anderson Cancer Center

ClinicalTrials.gov Identifier: NCT01471444

Brentuximab vedotin and combination chemotherapy for treating older patients with Hodgkin lymphoma

Researchers from Northwestern University are actively recruiting for a phase II, open-label trial of patients with previously untreated stage IIIV Hodgkin lymphoma. The researchers want to determine the effects of adding the monoclonal antibody brentuximab vedotin which targets the cell membrane protein CD30, to traditional combination chemotherapy. There will be only 1 treatment arm. In the study, all previously untreated patients with stage II-IV Hodgkin lymphoma, who are 60 years old or older, will receive sequential therapy with brentuximab vedotin, and then receive doxorubicin, vinblastine, and dacarbazine (AVD). Primary outcome is overall response rate after sequential brentuximab vedotin therapy with AVD chemotherapy. Secondary outcomes are progression-free survival, time to treatment failure, freedom from progression, and overall survival. The estimated enrollment is 48 patients.

Sponsor: Northwestern University, Robert H. Lurie Cancer Center

ClinicalTrials.gov Identifier: NCT01476410

Lung Cancer

Finding most effective radiation therapy for SCLC patients receiving cisplatin/ etoposide

A 2-part, phase III, multicenter trial is testing the most effective radiotherapy for patients with small cell lung cancer who are receiving cisplatin and etoposide. All patients will receive cisplatin/ etoposide and will be randomized to 1 of 3 treatment groups. Patients in arm 1 will receive standard-dose (45 Gy) thoracic radiotherapy delivered twice daily, 5 days a week for 3 weeks. Patients in arm 2 will receive 70 Gy radiotherapy once daily, 5 days a week for 7 weeks; and patients in arm 3 will receive 61.2 Gy once daily, 5 days a week for 16 days, then twice daily, 5 days a week for 9 days. The interim results will be analyzed, and the experimental arm with the most side effects will be discontinued. In part 2, standard radiotherapy will be compared with the remaining higher-dose regimen. Primary outcome measures are overall survival times. Secondary outcome measures are toxicity, complete and partial response rates, failure-free survival, local tumor progression, and rates of distant and intracranial metastases.

Sponsor: Cancer and Leukemia Group B, National Cancer Institute, Radiation Therapy Oncology Group

ClinicalTrials.gov Identifier: NCT00632853

Women’s Cancer

Treatment versus observation in women with stage III/IV gynecological cancers

A phase III trial is studying how well paclitaxel performs compared with polyglutamate paclitaxel or observation only in women with stage III/IV fallopian tube, ovarian, or peritoneal cavity cancer, which is in clinical complete response (CR) after platinum and taxane-based chemotherapy. In this multicenter study, the women are being randomized to 1 of 3 interventions: paclitaxel poliglumex, paclitaxel, or clinical observation. Sometimes women who are experiencing CR do not necessarily need more treatment, but researchers do not know if observation is better than maintenance therapy in these cases. The primary outcome is overall survival. Secondary outcomes are progression-free survival (PFS), toxicity, particularly peripheral neuropathy, and quality of life issues. Researchers also want to correlate biomarkers with overall PFS. After treatment, women will be followed every 3 months for 2 years, and then every 6 months for 3 years. Estimated enrollment is 1110 women (555 patients per treatment arm).

Sponsor: Gynecologic Oncology Group, National Cancer Institute

ClinicalTrials.gov Identifier: NCT00108745