Drug Shortages Impacting Cancer Clinical Trials

Cancer Drug	Description of Drug	Common Uses In Cancer Treatment and Clinical Trials	Approximate Number of Clinical Trials Currently Open in the United States
Bleomycin injection	Bleomycin is an antineoplastic antibiotic used as a single agent or in combination with other antineoplastic agents	Hodgkin's disease and non-Hodgkin's lymphoma in adults Testicular cancer in children and adults Malignant pleural effusion (as a sclerosing agent) Pleural effusion in children Mycosis fungoides in adults Osteosarcoma in adults AIDS-related Kaposi sarcoma in adults Lymphomas in children Palliative therapy in adults with squamous cell carcinoma, including ovarian cancer and head and neck cancer	16
Capecitabine tablets	Capecitabine is a fluorouracil prodrug	Treatment of metastic colorectal cancer An adjuvant to surgery in Dukes' C colon Cancer Treatment-resistant metastatic breast cancer alone or in combination with docetaxel Treatment-resistant, advanced or metastatic breast cancer in combination with lapatinib or ixabepilone	94
Carboplatin solution for injection	Carboplatin is a platinum-containing alkylating agent	Ovarian Cancer in adults (single agent or combination therapy) Small cell and non-small cell lung cancer in adults Brain tumors in adults Breast cancer in adults Bladder cancer in adults Cervical cancer in adults Hodgkin's and non-Hodgkin's lymphoma in adults Head and neck squamous cell cancer in adults Neuroblastoma in adults Testicular cancer in adults Wilms" tumor in adults Retinoblastoma in children	271
Cisplatin injection	Cisplatin is a platinum-based alkylating agent	Advanced transitional cell bladder cancer (single agent) Metastatic testicular cancer (combination therapy) Metastatic ovarian cancer (combination therapy) Squamous cell head and neck cancer Squamous cell head and ovarian cancer Lung cancer Osteosarcoma in children and adults Esophageal cancer Adrenal cortex carcinoma Breast cancer Endometrial cancer Liver cancer Brain tumors in children With other drugs as a conditioning regimen prior to bone marrow transplantation	233
Cytarabine injection	Cytarabine is a pyrimidine antimetabolite used as a single agent or in combination with other antineoplastic agents	Acute myelocytic leukemia in children and adults Acute myelocytic leukemia in children and adults Chronic myelocytic leukemia in children and adults Acute lymphocytic leukemia in children and adults Meningeal leukemia in children and adults Erythroleukemia in children and adults Non-Hodgkin’s lymphoma in children and adults Hodgkin’s lymphoma in adults Hematopoietic stem cell transplantation in adults	126
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Cancer Drug	Description of Drug	Common Uses In Cancer Treatment and Clinical Trials	Approximate Number of Clinical Trials Currently Open in the United States
Dacarbazine injection	Dacarbazine is an alkylating agent	Malignant metastatic melanoma (single agent) Hodgkin’s lymphoma in children and adults (combination therapy) Medullary carcinoma of the thyroid in adults Various soft tissue sarcomas in adults Islet cell carcinoma in adults Neuroblastoma in children Solid tumors in children	86
Daunorubicin hydrochloride injection	Daunorubicin hydrochloride is an anthracycline antineoplastic antibiotic	Remission induction in adults with acute myelogenous leukemia in combination with cytarabine Remission induction in children, adolescents, and adults with acute lymphocytic leukemia in combination with 6 other drugs Chronic myelogenous leukemia (combination therapy) Neuroblastoma in children Acute promyelocytic leukemia (combination therapy) Anaplastic large cell lymphoma in children	26
Doxorubicin injection	Doxorubicin is an anthracycline glycoside agent	Leukemias in children and adults Lymphomas in children and adults Soft tissue and bone sarcomas in children and adults Breast cancer in adults Gastric cancer in adults Ovarian cancer in adults Thyroid cancer in adults Small cell lung cancer in adults Transitional bladder cancer in adults AIDS-related Kaposi sarcoma in adults Refractory multiple myeloma in adults Ewing’s sarcoma in adults Adrenocortical cancer in adults Endometrial cancer in adults Islet cell cancer in adults Liver cancer in adults Neuroblastoma in children Wilms’ tumor in children	196 (includes doxorubicin liposomal injection)
Doxorubicin liposomal injection	Doxorubicin liposomal is an anthracycline glycoside agent encapsulated in liposomes	Refractory multiple myeloma in adults Refractory ovarian cancer in adults AIDS-related Kaposi sarcoma adults Refractory metastatic breast cancer adults	See doxorubicin injection directly above
Etoposide injection	Etoposide is a podophyllotoxin antineoplastic agent	Testicular cancer Small cell lung cancer Bladder cancer Acute myelocytic leukemia in children and adults Lymphomas Sarcomas Brain tumors in children Male and female reproductive system cancers Non-small cell lung cancer Gastric cancer Wilms’ tumor Multiple myeloma Adenocarcinoma of unknown primary cancer Hematopoietic stem cell transplantation	159
Fludarabine injection	Fludarabine is a purine antimetabolite	Progressive or refractory chronic B-cell lymphocytic leukemia in adults (single agent or combination therapy) Various leukemias in adults Various acute leukemias in children Non-Hodgkin’s lymphoma in adults Waldenström macroglobulinemia in adults Conditioning for hematopoietic stem cell transplantation in children and adults Various solid tumors in children	183
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	Description of Drug	Common Uses In Cancer Treatment and Clinical Trials	Approximate Number of Clinical Trials Currently Open in the United States
Fluorouracil injection	Fluorouracil is a pyrimidine antimetabolite	Colon cancer Rectal cancer Breast cancer Stomach cancer Pancreatic carcinoma Head and neck cancer Esophageal cancer Anal cancer Cervical cancer Endometrial cancer Ovarian cancer Prostate cancer Hepatic cancer Bladder cancer Renal cell carcinoma	173
Idarubicin hydrochloride injection	Idarubicin is a semisynthetic anthracycline	Acute myelocytic leukemia in adults (combination therapy) Acute lymphocytic leukemia in children and adults Chronic myelogenous leukemia in adults Breast cancer in adults Autologous hematopoietic stem cell transplantation in adults Acute nonlymphocytic leukemia in children Solid tumors in children	16
Irinotecan injection	Irinotecan is a topoisomerase type I DNA inhibitor most often used in combination with other antineoplastic agents	Metastatic colon and rectal cancer (combination therapy with fluorouracil and leucovorin as first-line treatment) Recurrent or progressive colon or rectal cancer (single agent) Cervical cancer Gastric cancer Lung cancer Central nervous system tumors Solid tumors in children	89
Leucovorin calcium injection	Leucovorin is a folinic acid product	Colorectal cancer in adults (combined with fluorouracil) An alternative to oral therapy in the treatment of megaloblastic anemias due to folic acid deficiency Methotrexate rescue in osteogenic sarcoma in children and adults Toxicity reduction in patients with impaired methotrexate elimination Toxicity reduction after inadvertent folic acid antagonist overdose Methotrexate rescue in non-Hodgkin’s lymphoma	83
Mesna injection	Mesna is a prophylactic agent	Hemorrhagic cystitis reduction after treatment with ifosfamide, an antineoplastic alkylating agent used to treat various cancers	39
Methotrexate injection	Methotrexate is an antimetabolite that inhibits dihydrofolic acid reductase	Breast cancer Epidermoid cancers of the head and neck Advanced mycosis fungoides (cutaneous T-cell lymphoma) Lung cancer Advanced non-Hodgkin’s lymphomas (combination therapy) Meningeal leukemia (intrathecal) Soft tissue sarcoma	108
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Cancer Drug	Description of Drug	Common Uses In Cancer Treatment and Clinical Trials	Approximate Number of Clinical Trials Currently Open in the United States
Mitomycin injection	Mitomycin is an antineoplastic antibiotic	Palliative treatment of disseminated adenocarcinoma of the stomach or pancreas in adults (combination therapy) Mesothelioma in adults Squamous cell carcinoma of the head and neck, lungs, or cervix in adults Anal cancer in adults Bladder cancer in adults (intravesicular use) Breast cancer in adults Colorectal cancer in adults Hepatocellular cancer in adults (intraarterial use)	10
Octreotide injection	Octreotide is an octapeptide that mimics naturally occurring somatostatin	Long-term treatment of severe diarrhea and flushing associated with metastatic carcinoid tumors Long-term treatment of watery diarrhea associated with vasoactive intestinal peptide-secreting tumors	10
Paclitaxel injection	Paclitaxel is a mitotic inhibitor	Ovarian cancer (single agent) Breast cancer (single agent) Adjuvant therapy in breast cancer Non-small cell lung cancer (combination therapy) AIDS-related Kaposi sarcoma in adults (single agent) Bladder cancer in adults Prostate cancer in adults Testicular cancer in adults Esophageal cancer in adults Endometrial cancer in adults Cervical cancer in adults Squamous cell head and neck cancer in adults Small cell lung cancer in adults Gastric cancer in adults Germ cell tumors in adults Refractory leukemia in children Recurrent Wilms’ tumor in children	267
Thiotepa injection	Thiotepa is a cytotoxic agent related chemically and pharmacologically to nitrogen mustard	Superficial papillary carcinoma of the urinary bladder Lymphomas, including lymphosarcoma and Hodgkin’s lymphoma Palliation of adenocarcinoma of the breast Palliation of adenocarcinoma of the ovary Control of intracavitary effusions secondary to diffuse or localized neoplastic diseases of serosal cavities	34
Vincristine injection	Vincristine is an antineoplastic vinca alkaloid agent	Acute leukemia Hodgkin’s lymphoma (combination therapy) Non-Hodgkin’s lymphoma (combination therapy) Rhabdomyosarcoma (combination therapy) Neuroblastoma (combination therapy) Wilms’ tumor (combination therapy) Kaposi sarcoma Breast cancer Bladder cancer Small cell lung carcinoma Brain tumors Multiple myeloma Chronic lymphocytic leukemia Chronic myelocytic leukemia	119

Sources:

American Society of Health-System Pharmacists. Current drug shortage bulletins. Available at: http://www.ashp.org/DrugShortages/Current/. Accessed October 7, 2011.

[Note: The individual bulletins are derived from the American Hospital Formulary Service Drug Information Manual, which is published by the American Society of Health-System Pharmacists.]

US National Institutes of Health. Search for clinical trials. Available at: clinicaltrials.gov. Accessed November 14, 2011. Search terms used to determine the number of clinical trials by drug are as follows: main search term = drug name (without descriptors such as injection, tablets, etc.); recruitment = open studies (open recruitment status included trials that were recruiting, not yet recruiting, and available for expanded access); unknown status = excluded; study results = all studies; study type = all studies; conditions = cancer; and locations = United States.

Disclaimer: Drug usage is a complex medical decision and users of the information provided here should exercise their own independent judgment. This information should not in any way be interpreted as “advice” for the prescription of medication for any of the conditions listed. The intent of this chart is to raise public awareness about the magnitude of cancer drug shortages and the breadth of malignant diseases whose treatment may be compromised by the lack of drug availability.