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Clinical Trials Monthly - June 2011

Dear Colleague,

This month we’ve included newly opened Phase I, II, and III trials as well as other selected ongoing trials for:

Each study summary has a link to the specific details about that trial in our online Clinical Trials Database. The complete list of trials recruiting participants at Seattle Cancer Care Alliance can be found at


Exciting New Drug Inhibits Hedgehog Pathway

Exciting news for pancreas cancer patients, this clinical trial exemplifies Fred Hutchinson Cancer Research Center and SCCA’s ability to successfully translate leading-edge science to patient care. This trial follows directly from research performed by an international team of scientists, including the Hutchinson Center’s Dr. Sunil R. Hingorani (below).

IPI-926 is a novel, small, oral molecule that inhibits signaling between a pancreas cancer cell and surrounding fibroblasts that support its growth and survival. Inhibition of this so-called Hedgehog signaling pathway represents a fundamentally new approach for addressing a broad range of cancers, including pancreas cancer.

As reported in the journal Science in 2009, IPI-926 was shown to deplete the dense, scar-like stromal tissue surrounding tumors in mice genetically engineered to develop pancreas cancer. This led to an increase in blood flow allowing chemotherapy to be more effectively delivered to the tumor. Without IPI-926, the stromal tissue prevented the chemotherapy from penetrating tumors. As a result, much higher response rates were seen than occurs with gemcitabine alone, the current standard of care.

At the annual American Society of Clinical Oncology (ASCO) meeting in Chicago on June 4, Infinity Pharmaceuticals, Inc. announced encouraging results from the Phase 1b portion of this trial showing that IPI-926 in combination with gemcitabine was well-tolerated, and partial responses were experienced in 31 percent of patients. The historic overall response rate to gemcitabine is less than 10 percent.

“This overall strategy of targeting the supporting tumor microenvironment, or stroma, in combination with therapies against the cancer cell itself holds great promise for improving treatment response in patients with pancreas cancer and represents a new conceptual approach to cancer treatment in general,” said Dr. Hingorani.

Based on these results of the Phase 1b trial, the randomized, doubleblind, placebo-controlled Phase 2 portion of the trial opened in February 2011. This trial compares IPI-926 treatment with gemcitabine against a placebo and gemcitabine and is actively enrolling patients at SCCA.


Breast Cancer

Vorinostat for Stage IV Breast Cancer (6856)
A Pilot Study of Vorinostat (Zolinza) to Restore Sensitivity to Aromatase Inhibitor Therapy (NCT01153672).

Vorinostat may stop the growth of tumor cells by blocking enzymes needed for cell growth. It may also make tumor cells more sensitive to aromatase inhibitor therapy. This trial evaluates vorinostat in patients with Stage IV breast cancer receiving aromatase inhibitor therapy, including male breast cancer patients.

Patients will receive an eight-week treatment cycle at SCCA that includes imaging for two weeks before receiving vorinostat. Treatment will occur daily for weeks 1 and 2, followed by imaging on day 15. Therapy continues until week eight with imaging at the end of the cycle. Treatment will continue every cycle in the event of absence of disease progression, unacceptable toxicity, or if consent is withdrawn. At the start of week three, patients will resume their previous aromatase inhibitor therapy. Switching to another brand or type (steroidal or non-steroidal) of therapy will not be allowed.

Investigator: Hannah Linden, MD


Liver Cancer

RAD001 for Advanced Hepatocellular Carcinoma (HCC) (20100900)
A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients with Advanced Hepatocellular Carcinoma after Failure of Sorafenib Treatment – The EVOLVE-1 Study. (NCT01035229)

This study compares treatment with RAD001 (everolimus) plus the best supportive care (BSC) to placebo plus BSC in patients whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

Everolimus is approved in many countries to treat patients with advanced kidney cancer. Its trade name is Afinitor®. Everolimus is approved in the United States for subependymal giant cell astrocytoma (SEGA), a brain tumor seen with a genetic condition called tuberous sclerosis (TS). Several hundred kidney and heart transplant patients have been treated for over two years with everolimus (sold as Certican® in the EU and Zortress® in the US).

The drug helps stop the multiplication of immunological cells which can cause organ rejection.

Two study groups: One will receive three everolimus tablets daily (total of 7.5 milligrams); the other will receive three matching placebo tablets daily. Patients will receive supportive care, such as pain medication or nutritional support. The first dose of study tablets (three tablets) will be given at SCCA. Patients will receive enough tablets to continue treatment at home, returning to the clinic once every three weeks as long as patients receive study tablets.

Investigator: Samuel Whiting, MD, PhD

OSI-906 for Advanced Hepatocellular Carcinoma (UW10034)
A Randomized, Placebo-controlled, Double-blinded Phase II Study of Second-line Treatment with OSI-906 in Patients with Advanced Hepatocellular Carcinoma (HCC) After Failure of First-line Treatment with Sorafenib. (NCT01101906)
This study will determine whether OSI-906 (study drug) prolongs the time until disease worsens, prolongs survival, stops the growth, or shrinks tumor size, and what the most common side effects of OSI-906 are when given to subjects with liver cancer (hepatocellular carcinoma).

Patients will come to SCCA every three weeks. For the first three weeks, patients will need to return to SCCA or another facility once a week for blood tests. After six months, clinic visits will be every two treatment periods (about six weeks). In addition to Treatment Period, patients will be asked to stay at the clinic for up to 14 hours. It is important to understand that this study requires extra time from patients to visit the clinic for these appointments.

Treatment includes one tablet of OSI-906 or placebo by mouth twice daily, at approximately the same time each day (morning and evening, every 12 hours). Side effects may require lowering the dose of OSI-906 or placebo. If the dosage is changed during the study, the number of tablets patients take may increase relative to the dose. Computer tomography (CT) scans of the patient’s tumor(s) will be done every two treatment periods (approximately six weeks apart) to measure the disease.

Investigator: William Harris, MD


Ovarian Cancer

FDG PET for Advanced Ovarian Cancer (FHCRC-7009)
This study uses FDG PET and biomarkers to determine treatment response in women with advanced ovarian cancer or primary peritoneal cancer (Stage IIIC–IV).
The goals of the study are to determine the association between FDG measures of glycolysis with chemo-resistance and to determine if treatment-related changes in the tumor’s FDG metabolic activity can predict treatment response, time to recurrence, and disease-free survival.

This study is recruiting previously untreated patients with biopsy/ cytology-proven ovarian carcinoma or primary peritoneum who are candidates for neoadjuvant chemotherapy.

Patients will have three visits to University of Washington Medical Center (UWMC) to have a research FDG-PET imaging scan (three-hour visit). A research FDG-PET scan occurs prior to chemotherapy cycle one and post cycles one and three. PET scans must take place at UWMC, however patients may choose to receive their chemotherapy at either UWMC, SCCA, or a clinic of their choosing. Patients will need to be referred to the SCCA Gynecologic Oncology Clinic to be considered for the study.

Investigator: Joseph Rajendran, MD

Temsirolimus + Carboplatin/Paclitaxel for Newly Diagnosed Stage III-IV Ovarian Clear Cell Carcinoma (GOG-0268)
A Phase II Evaluation of Temsirolimus (CC1-779) (NCI Supplied Agent: NSC#683864, IND# 61010) in Combination with Carboplatin and Paclitaxel followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary (NCT01196429).
This trial looks at how well first-line therapy with temsirolimus (Torisel), carboplatin, and paclitaxel work together in treating newly diagnosed Stage III or Stage IV clear cell ovarian cancer.

Patients will be treated every three weeks for six cycles with temsirolimus IV (study drug) on days one and eight, carboplatin IV on day one, and paclitaxel on day one. This is followed by maintenance with temsirolimus on days one, eight, and 15 every three weeks for up to 11 additional cycles. Response is evaluated every other cycle for the first six months and then every three months after that. Patients can be treated at PSOC members’ institutions.

Investigator: Benjamin Greer, MD


Pancreas Cancer

IPI-926 w/Gemcitabine for Metastatic Pancreatic Cancer (UW10026)
A Phase Ib/II Study Evaluating IPI-926 in Combination with Gemcitabine in Patients with Metastatic Pancreatic Cancer (NCT01130142).

The purpose of this study is to find out if IPI-926 given with gemcitabine (a drug approved for different types of cancers as well as pancreas cancer), is as safe and effective as gemcitabine alone. In this study, IPI-926 or placebo in combination with gemcitabine will be tested as therapy for people who have not yet had any cancer treatment for metastatic pancreas cancer.

Participants will get IPI-926 or placebo in combination with gemcitabine. They will not receive both regimens. They will receive 1000 mg/m2 of gemcitabine (infusion) once a week for three weeks of a four-week cycle in combination with 160 mg of IPI-926 (capsule form taken once a day) or placebo daily. Patients undergo imaging evaluations after the second cycle and again after every other cycle (approximately every 56 days) beginning at the last week of cycle two.

Investigator: Samuel Whiting, MD, PhD

HyperAcute® Pancreatic Cancer Vaccine for Surgically Resected Pancreatic Cancer (7259)
Phase III Study of Chemotherapy and Chemoradiotherapy with or without the HyperAcute® Pancreatic Cancer Vaccine for Surgically Resected Pancreas Cancer Patients (NCT01072981)

This study will look at the effect of a new vaccine when added to standard therapy. The HyperAcute® Pancreatic Cancer Vaccine will be given in combination with standard care treatment (gemcitabine—six monthly cycles one day per week for three weeks in a row followed by a one week holiday; or gemcitabine given before and after a course of radiation therapy combined with 5-fluorouracil). The choice of standard therapy will be determined by the patient and their doctor. The alternative is that patients will get standard care alone without the vaccine.

Investigator: Samuel Whiting, MD, PhD 


Prostate Cancer

Cabozantinib (XL184) for Advanced Malignancies. A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors (NCT00940225)
“Updated preliminary results from this trial were presented at ASCO several weeks ago. The striking results from this drug continue to generate excitement among national leaders in prostate cancer research. We’re very excited to participate and be able to offer this novel investigational agent to Puget Sound patients.”
Celestia Higano, MD

This is an ongoing Phase II clinical study with unprecedented activity in prostate cancer, (also active in other cancers). (Will be open for ovarian cancer patients in the near future.) This study hopes to determine whether or not Cabozantinib (XL184) demonstrates anti-tumor activity in selected tumor types. It appears to be causing regressions in bone scans (bone metastases) unlike anything ever seen before. It also seems to be shrinking metastatic tumors in other sites.

After screening, patients must answer pain/analgesia questionnaires for at least four of seven days before receiving the first dose of study drug on Week 1 Day 1. Thereafter, the patient will return to SCCA every three weeks for study visits, bone scan, and CT every six weeks at SCCA. The study treatment period will last until progression or unacceptable toxicity occurs. Patients will be required to contact acentralized call center to report pain status and analgesia use prior to every six weeks for at least four out of seven consecutive days.

Investigator: Celestia Higano, MD

Referral or Consultation

To discuss treatment options for your patients with a physician, please call our intake office at (206) 288-SCCA (7222) or (800) 804-8824. To read the full description of each trial and or enroll your patients online, please see


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