March 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.

Breast Cancer

Radiation Therapy After Surgery for Early Invasive Breast Cancer

This phase III study is comparing standard breast irradiation to breast irradiation plus regional irradiation (to the ipsilateral supraclavicular, axillary, and internal mammary nodes) in women who have undergone surgery for early-stage invasive breast cancer. The primary outcome measure is overall survival. Secondary outcome measures include disease-free survival, toxicity, quality of life, and cosmetic outcome. Participants are stratified according to the number of positive nodes, number of axillary nodes removed, type of chemotherapy, hormonal therapy, number of axillary lymph nodes excised, and participating center. About 1822 patients are expected to be enrolled in the study, which is intended for completion in December 2013.

Sponsor: NCIC Clinical Trials Group

ClinicalTrials.gov Identifier: NCT00005957

Endocrine Therapy With or Without Anti- VEGF Therapy for Advanced Breast Cancer

This phase III study will examine the use of tamoxifen or letrozole alone or combined with bevacizumab in women with hormone receptor-positive stage III or IV breast cancer. Participants will be randomized to receive either tamoxifen citrate or letrozole once daily on days 1 to 21 or tamoxifen or letrozole once daily on days 1 to 21 plus bevacizumab intravenously on day 1. In both arms, treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. The primary outcome measures include progression-free survival, the rate of adverse events (especially stroke, proteinuria, thrombosis, and hypertension in patients treated with tamoxifen), and toxicity. The target recruitment for the study is 502 patients.

Sponsor: Cancer and Leukemia Group B

ClinicalTrials.gov Identifier: NCT00601900

Gynecologic Cancer

Carboplatin With or Without Liposomal Doxorubicin for Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

This phase III study is comparing treatment with carboplatin with or without liposome doxorubicin in women who have recurrent ovarian epithelial or primary peritoneal cancer. Subjects are stratified according to disease measurability, number of disease sites, and serous tumor histology and randomized to 1 of 2 treatment arms. One group of women will receive carboplatin intravenously (IV) over 15 minutes. The other group will receive carboplatin IV over 15 minutes and pegylated doxorubin HCl liposome IV over 1 hour on day 1. Treatment in both arms is repeated every 4 weeks for a total of 15 courses in the absence of disease progression or unacceptable toxicity. The initial follow-up is at 4 weeks, then every 6 months for 3 years, and then annually for 7 years.

Sponsor: Southwest Oncology Group

ClinicalTrials.gov Identifier: NCT00043082

Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in Cervical Cancer

This phase III study will determine whether administering adjuvant systemic chemotherapy after chemoradiotherapy improves disease-free survival versus chemoradiotherapy alone in women with high-risk, early-stage cervical cancer found to have positive nodes and/or positive parametria after radical hysterectomy. Participants are randomized to 1 of 2 treatment arms. One group of patients will undergo standard electron-beam radiation therapy or intensity-modulated radiotherapy to the pelvis once daily 5 days a week for 5 to 6 weeks; they will also receive concurrent cisplatin intravenously (IV) over 1 hour once weekly for 6 weeks. Patients assigned to the second arm will receive chemotherapy as in arm 1, and, starting 4 to 6 weeks after the completion of chemoradiotherapy, will also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1; treatment is repeated every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Sponsor: Radiation Therapy Oncology Group

ClinicalTrials.gov Identifier: NCT00980954

Lung Cancer

Sunitinib Maintenance Therapy in Advanced Lung Cancer

This phase III study is comparing sunitinib with placebo as maintenance therapy in patients with stage IIIB or IV non-small cell lung cancer who have stable or responding disease after prior treatment with 4 courses of platinum-based chemotherapy. Participants are stratified according to ECOG performance status, disease stage, prior treatment with bevacizumab, and gender. After the completion of treatment, patients will be followed every 3 months for 1 year, every 6 months for 1 year, and periodically for 3 years. The primary outcome measure is progression-free survival. Secondary outcome measures include grade and type of toxicity, response rate, and overall survival. The study has a target recruitment of 244 patients.

Sponsor: Cancer and Leukemia Group B

ClinicalTrials.gov Identifier: NCT00693992

Amifostine for Stage II or III Non-Small Cell Lung Cancer

This phase III study is evaluating whether the addition of the radioprotector amifostine can decrease the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during concurrent hyperfractionated radiotherapy and chemotherapy with paclitaxel and carboplatin in patients with stage II, IIIA, or IIIB non-small cell lung cancer. The trial will also examine the differences in quality of life and symptom distress between patients randomized to amifostine and patients not receiving amifostine. Participants are stratified according to disease stage, Karnofsky Performance Scale status, and age. The 244-patient study is being conducted at 264 sites.

Sponsor: Radiation Therapy Oncology Group

ClinicalTrials.gov Identifier: NCT00003313

Supportive Care

Radiopharmaceuticals and Zoledronic Acid for Bone Metastases

This phase III study is testing whether zoledronic acid, vitamin D, and calcium is superior to zoledronic acid, vitamin D, and calcium plus either strontium 89 or samarium 153 in the delaying of bone problems in patients with bone metastases from lung, breast, and prostate cancer. The primary outcome measure is the time to development of a malignant skeletal-related event (SRE). Secondary outcome measures include SRE at 1 year, overall survival, changes in quality of life, changes in pain control, and the utility and costeffectiveness of the use of radiopharmaceuticals and bisphosphonates. The study is aiming to recruit about 352 patients with an estimated primary completion date of March 2013.

Sponsor: Radiation Therapy Oncology Group

ClinicalTrials.gov Identifier: NCT00365105