Current Clinical Trials of the Cancer Trials Support Unit (CTSU), an NCI Pilot Program

The Cancer Trials Support Unit (CTSU) is a pilotprogram sponsored by the National Cancer Institute (NCI). The CTSU has twoprimary functions. It centralizes regulatory support for all adult CooperativeGroup trials (phases I- III), thereby reducing duplication among Group membersregarding credentialing, compliance with federal regulations, and institutionalreview board (IRB) activities. It also provides all Group members and select non-Groupmembers with access to phase III treatment trials.

Clinical Trials Referral Resource is designed to serve as a ready reference for oncologists to help identify clinical trials that might be suitable for their patients. We hope it will also enhance accrual to clinical trials by informing practicing oncologists of ongoing protocols. Currently in the United States less than 10% of eligible adult patients are entered into clinical trials. The result is a delay in answering important therapeutic and scientific questions and disseminating therapeutic advances to the general oncology community.

It should be emphasized that including a specific trial does not imply that it is more important than another trial. Among the criteria for selection are that the trial is addressing an important question and is not expected to close in the immediate future (less than 1 year), and that initial staging or laboratory tests required for patient eligibility are widely practiced and available. Information on other protocols can be accessed via Physician’s Data Query (PDQ).*

We emphasize that this is an attempt to encourage referral of patients to these trials. We are specifically not soliciting additional members for the cooperative groups, nor are we suggesting how practicing oncologists should be treating patients who are not in a study.

This month’s installment of Clinical Trials Referral Resource is devoted to current clinical trials of the Cancer Trials Support Unit, a National Cancer Institute pilot program.

For patient entry information, see the individual trials.

* PDQ is a comprehensive database service provided by the National Cancer Institute’s International Cancer Information Center and Office of Cancer Communications for retrieval of cancer treatment information, including peer-reviewed statements on treatment options, supportive care, screening, and prevention; and an international clinical trials registry. For more information on PDQ, online access is available at www.cancer.gov/cancer_information/pdq/, or contact the Cancer Information Service offices (1-800-4-CANCER).

There are currently 28 active CTSU-designated trials in the following tumortypes: breast, gastrointestinal, genitourinary, adult leukemia, lung, andmyeloma. The list is expanding to include other diseases such as melanoma,ovarian cancer, and sarcoma. Physicians registered with the CTSU can enrollpatients in these trials even if they are not members of the Cooperative Groupthat is leading the trial. The CTSU will potentially allow new treatments to beavailable to more patients, regardless of their geographic location, becausemany more oncologists will now have access to these trials.

Although originally a venue for oncologists who belonged to the adultCooperative Groups,[1] the CTSU has recently expanded to include oncologists whoare not members of the Cooperative Groups. A physician in the UnitedStates who is interested in becoming a CTSU-credentialed investigator and is nota member of a Cooperative Group should complete an online Interest Form (www.ctsu.org/int_member_form.asp). A postcard version of the Interest Form can be obtained from theCTSU Help Desk by calling (888) 823-5923. However, before physicians notassociated with NCI’s Cooperative Group program can enroll patients inclinical trials, they must meet standards similar to those of Cooperative Groupmembers (ie, credentials must be verified, site preparedness must be assessed).Non-Group members interested in trials available via the CTSU can find out howto become CTSU members by visiting the CTSU website (www.ctsu.org).

Registration With the CTSU

Registration with the CTSU allows unrestricted access to a broad menu ofNCI-sponsored adult phase III Cooperative Group protocols outside of theregistrant’s respective Cooperative Group. Members can receive financialreimbursement or funding credit for each patient enrolled, and credit towardsCooperative Group membership accrual requirements even when the registrant’srespective Cooperative Group does not sponsor the protocol.

Canadian investigators affiliated with a Cooperative Group who are interestedin participating in CTSU trials need to register with the CTSU. Once Canadianregulatory approval of the study has been obtained, notification of this will beposted on the CTSU registered member website. At that time, the CTSU willprovide a French translation of the consent and post it along with theInvestigator Agreement, Qualified Investigator Undertaking, Clinical Trials SiteInformation, and Research Ethics Board Attestation forms on theprotocol-specific page of the CTSU registered member website. For all Canadiansites, the trial may not be locally activated until required ethics andregulatory documents are completed and forwarded to the CTSU.

Conclusion

The CTSU serves as a cornerstone in the NCI’s ongoing effort to restructureits clinical treatment trials program to better serve clinical investigators inthe field and their patients. By providing technical and administrative supportto complement the top quality, peer-reviewed research efforts of NCI’sClinical Trials Cooperative Groups, the CTSU is designed to help make theoverall system more flexible, efficient, and cost-conscious for physicians.Doing so should assure that the NCI achieves its ultimate goal of providing newand innovative cancer treatments to more patients via carefully conductedclinical trials.

Upcoming CTSU Events

The CTSU will be present at the following upcoming conferences:

• Society of Clinical Research Associates (SOCRA): September 19-22, 2002, Philadelphia, Pa

• North Central Cancer Treatment Group (NCCTG): October 8-11, 2002, Rochester, Minn

• Southwest Oncology Group (SWOG): October 23-27, 2002, San Antonio, Tex

• Cancer and Leukemia Group B (CALGB): November 7-10, 2002, Tampa, Fla

• Eastern Cooperative Oncology Group (ECOG): November 16-18, 2002, Miami, Fla

CTSU Contact Information

General questions regarding the CTSU may be submitted online to ctsucontact@westat.com.The General Information number, (888) 823-5923, will handle general inquiriesabout the CTSU, including information about clinical studies, investigatorregistration, and other issues. The Patient Registrar number, (888) 462-3009, isspecifically for patient enrollment and adverse event reporting.

Active Trials

Title: Phase III Randomized Study of Adjuvant Cyclophosphamide andDoxorubicin Versus Paclitaxel in Women With High-Risk Node-Negative BreastCancer
Protocol Number: CLB-40101
Participating Institutions: CALGB
Contact: CALGB Central Office, (773) 702-9171; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Doxorubicin and CyclophosphamideWith or Without Dexrazoxane, Followed By Paclitaxel With or Without Trastuzumab(Herceptin), Followed By Surgery and Radiotherapy With or Without Trastuzumab inWomen With HER-2+ Stage IIIA or IIIB or Regional Stage IV Breast Cancer
Protocol Number: CLB-49808
Participating Institutions: CALGB, CTSU
Contact: CALGB Central Office, (773) 702-9171; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Adjuvant Chemotherapy ComprisingStandard Cyclophosphamide, Methotrexate, and Fluorouracil (CMF) or Doxorubicinand Cyclophosphamide (AC) Versus Oral Capecitabine in Elderly Women WithOperable Adenocarcinoma of the Breast
Protocol Number: CLB-49907
Participating Institutions: CALGB, CTSU, EPP (Expanded ParticipationProject), NCCTG
Contact: CALGB Central Office, (773) 702-9171
Latest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Paclitaxel and Carboplatin VersusNo Adjuvant Chemotherapy After Resection in Patients With Stage IB Non-SmallCell Lung Cancer
Protocol Number: CLB-9633, RTOG-9616
Participating Institutions: CALGB, NCCTG, RTOG, EPP (ExpandedParticipation Project), CTSU
Contact: CALGB Central Office, (773) 702-9171; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Paclitaxel Via One Hour InfusionEvery Week Versus Three Hour Infusion Every 3 Weeks With or Without Trastuzumab(Herceptin) in Patients With Inoperable, Recurrent, or Metastatic Breast CancerWith or Without Overexpression of HER2-Neu
Protocol Number: CLB-9840
Participating Institutions: CALGB, EPP (Expanded Participation Project),CTSU
Contact: CALGB Central Office, (773) 702-9171; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Dexamethasone With or WithoutThalidomide in Patients With Newly Diagnosed Multiple Myeloma
Protocol Number: E-E1A00
Participating Institutions: ECOG, CTSU
Contact: Jean McDonald, (617) 632-3610; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Paclitaxel With or WithoutBevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
Protocol Number: E-2100
Participating Institutions: ECOG, CTSU, EPP (Expanded ParticipationProject)
Contact: Jean McDonald, (617) 632-3610; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Oxaliplatin, Fluorouracil, andLeucovorin Calcium With or Without Bevacizumab Versus Bevacizumab Only inPatients With Previously Treated Advanced or Metastatic ColorectalAdenocarcinoma
Protocol Number: E-3200
Participating Institutions: ECOG, CTSU, EPP (Expanded ParticipationProject)
Contact: Jean McDonald, (617) 632-3610; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase II/III Randomized Study of Paclitaxel and CarboplatinWith or Without Bevacizumab in Patients With Advanced, Metastatic, or RecurrentNon-Squamous Cell Non-Small Cell Lung Cancer
Protocol Number: E-4599
Participating Institutions: ECOG, CTSU, EPP (Expanded ParticipationProject)
Contact: Jean McDonald, (617) 632-3610
Latest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Paclitaxel and Carboplatin Withor Without Gemcitabine, Doxorubicin HCl Liposome, or Topotecan in Patients WithStage III or IV Ovarian Epithelial or Primary Peritoneal Carcinoma
Protocol Number: GOG-0182, SWOG-G0182
Participating Institutions: GOG, SWOG, CTSU
Contact: Michael A. Bookman, ma_bookman@fccc.edu; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Intermittent Versus ContinuousAndrogen Suppression in Patients With Prostate Specific Antigen Progression inthe Clinical Absence of Distant Metastases After Prior Radiotherapy for ProstateCancer
Protocol Number: CAN-NCIC-JPR7, CAN-NCIC-PR7, CTSU, SWOG-JPR7
Participating Institutions: NCIC (National Cancer Institute of Canada),SWOG, CTSU
Contact: Juanita M. Crook, (416) 946-2125; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Consolidation Therapy With orWithout Strontium Chloride Sr 89 After Induction Chemotherapy in Patients WithAndrogen-Independent Prostate Cancer
Protocol Number: MDA-ID-00156, NCI-3410
Participating Institutions: M. D. Anderson Cancer Center
Contact: Shi-Ming Tu, (713) 792-2830
Latest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Oral Carboxyamidotriazole inPatients With Stage III or IV Non-Small Cell Lung Cancer
Protocol Number: NCCTG-NCCTG-972451
Participating Institutions: NCCTG, EPP (Expanded Participation Project),CTSU
Contact: Edith A. Perez, (904) 953-7283; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Adjuvant Doxorubicin andCyclophosphamide Followed by Docetaxel Versus Doxorubicin and Docetaxel VersusDoxorubicin, Docetaxel, and Cyclophosphamide in Women With Breast Cancer andPositive Axillary Lymph Nodes
Protocol Number: NSABP-B-30
Participating Institutions: NSABP, EPP (Expanded Participation Project),CTSU
Contact: Mary Ketner, (412) 330-4624; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Exemestane in PostmenopausalWomen With Resected Stage I, II, or IIIA Breast Cancer Who Have Completed FiveYears of Tamoxifen
Protocol Number: NSABP-B-33
Participating Institutions: NSABP, EPP (Expanded Participation Project),CTSU
Contact: Mary Ketner, (412) 330-4624; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Adjuvant Clodronate With orWithout Systemic Chemotherapy and/or Tamoxifen in Women With Early-Stage BreastCancer
Protocol Number: NSABP-B-34
Participating Institutions: NSABP, CTSU
Contact: Mary Ketner, (412) 330-4624; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Radiotherapy With Or WithoutBicalutamide in Patients With PSA Elevation Following Radical Prostatectomy forCarcinoma of the Prostate
Protocol Number: RTOG-9601, RTOG-R9601, SWOG-R9601
Participating Institutions: RTOG, SWOG, CTSU
Contact: Elaine Pakuris, (215) 574-3195; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Whole Breast Radiotherapy VersusObservation With or Without Optional Tamoxifen in Women With Good-Risk DuctalCarcinoma In Situ of the Breast
Protocol Number: CAN-NCIC-MA26, CLB-49801, RTOG-9804, RTOG-DEV-1026
Participating Institutions: RTOG, Memorial Sloan-Kettering Cancer Center,CALGB, EPP (Expanded Participation Project), SWOG, NCIC (National CancerInstitute of Canada), CTSU
Contact: Elaine Pakuris, (215) 574-3195; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Androgen Suppression andRadiotherapy With or Without Subsequent Paclitaxel, Estramustine, and Etoposidein Patients With Localized High-Risk Prostate Cancer
Protocol Number: RTOG-9902, RTOG-DEV-1020
Participating Institutions: RTOG, University of Michigan Medical Center
Contact: Elaine Pakuris, (215) 574-3195; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Neoadjuvant Total AndrogenSuppression and Radiotherapy in Patients With Intermediate-Risk Adenocarcinomaof the Prostate
Protocol Number: RTOG-9910
Participating Institutions: RTOG, CTSU
Contact: Elaine Pakuris, (215) 574-3195; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Adjuvant Study of Radiotherapy WithHormonal Therapy Versus Radiotherapy Alone Versus Hormonal Therapy Alone inPatients With High-Risk Stage III Prostate Cancer
Protocol Number: RTOG-P-0011, RTOG-DEV-1037
Participating Institutions: RTOG, CTSU
Contact: Elaine Pakuris, (215) 574-3195; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Carboplatin and Paclitaxel Withor Without Tirapazamine in Patients With Advanced Non-Small Cell Lung Cancer
Protocol Number: SWOG-S0003
Participating Institutions: SWOG, EPP (Expanded Participation Project),CTSU, Southwest Oncology Group CCOP Ordering Group, CALGB
Contact: Marj Godfrey, (210) 677-8808; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Neoadjuvant Doxorubicin andCyclophosphamide With or Without Filgrastim (G-CSF) in Women With Inflammatoryor Estrogen Receptor Negative Locally Advanced Breast Cancer
Protocol Number: SWOG-S0012
Participating Institutions: SWOG, EPP (Expanded Participation Project),CTSU
Contact: Marj Godfrey, (210) 677-8808; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Cisplatin, Etoposide,Radiotherapy, and Docetaxel With or Without ZD 1839 in Patients WithUnresectable Stage III Non-Small Cell Lung Cancer
Protocol Number: CAN-NCIC-BR.15, NCCTG-S0023, SWOG-S0023
Participating Institutions: SWOG, NCCTG, NCIC (National Cancer Instituteof Canada), CTSU, EPP (Expanded Participation Project), Southwest Oncology GroupCCOP Ordering Group
Contact: Marj Godfrey, (210) 677-8808; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Surgery With or WithoutPreoperative Paclitaxel and Carboplatin in Patients With Stage IB, II, orSelected IIIA Non-Small Cell Lung Cancer
Protocol Number: E-S9900, NCCTG-S9900, RTOG-L0015, SWOG-S9900
Participating Institutions: SWOG, ECOG, NCCTG, CTSU, RTOG, ACOSOG, M. D.Anderson Cancer Center, Southwest Oncology Group CCOP Ordering Group, NCIC(National Cancer Institute of Canada)
Contact: Marj Godfrey, (210) 677-8808; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Docetaxel and Estramustine VersusMitoxantrone and Prednisone in Patients With Hormone-Refractory, MetastaticAdenocarcinoma of the Prostate
Protocol Number: CLB-99808, NCCTG-S9916, SWOG-S9916
Participating Institutions: SWOG, CALGB, EPP (Expanded ParticipationProject), NCCTG, CTSU, Southwest Oncology Group CCOP Ordering Group
Contact: Marj Godfrey, (210) 677-8808; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Phase III Randomized Study of Adjuvant Androgen DeprivationTherapy With or Without Mitoxantrone and Prednisone After Radical Prostatectomyin Patients With High-Risk Adenocarcinoma of the Prostate
Protocol Number: CLB-99904, SWOG-S9921
Participating Institutions: SWOG, EPP (Expanded Participation Project),CALGB, CTSU, Southwest Oncology Group CCOP Ordering Group, ECOG
Contact: Marj Godfrey, (210) 677-8808; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: Lung Cancer Specimen Repository Protocol, Ancillary
Protocol Number: S9925
Participating Institutions: SWOG, CTSU, NCIC (National Cancer Instituteof Canada), Southwest Oncology Group CCOP Ordering Group
Contact: Marj Godfrey, (210) 677-8808

Approved Trials

Title: Phase III Randomized Study of Carboplatin, Paclitaxel, andRadiotherapy With or Without Thalidomide in Patients With Stage III Non-SmallCell Lung Cancer
Protocol Number: E-3598
Participating Institutions: ECOG, EPP (Expanded Participation Project)
Contact: Jean McDonald, (617) 632-3610; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

Title: A Clinical Trial Comparing Anastrozole With Tamoxifen inPostmenopausal Patients With Ductal Carcinoma In Situ (DCIS) UndergoingLumpectomy With Radiation Therapy
Protocol Number: NSABP-B-35
Participating Institutions: NSABP, CTSU
Contact: Mary Ketner, (412) 330-4624

Title: Phase III Study of Fluorouracil and Leucovorin Calcium With orWithout Oxaliplatin in Patients With Stage II or III Carcinoma of the Colon
Protocol Number: NSABP-C-07
Participating Institutions: NSABP
Contact: Mary Ketner, (412) 330-4624; for a complete listing ofstudy contacts, click hereLatest Information:http://www.cancer.gov/clinical_trials/

References:

1. Michaels M, Denicoff AM, Bright MA, et al: Current initiatives at theNational Cancer Institute. Oncology Issues 17:33-35, 2002.