Clinical trial · Interventional

Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma

PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION

NCT00002625CI-TRIAL-00009386completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Phase I trial to study the effectiveness of topotecan and radiation therapy in treating patients who have solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
low-LET electron therapy	Radiation	—	UNRESOLVED
low-LET photon therapy	Radiation	—	UNRESOLVED
topotecan hydrochloride	Drug	Topotecan	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Arm I
description
Radiosensitization plus Radiotherapy. Topotecan hydrochloride, TOPO, NSC-609699; plus external-beam irradiation using linear accelerators with photon energies between 4 and 10 MV (electrons acceptable for the boost field).
interventionNames
1. Drug: topotecan hydrochloride
2. Radiation: low-LET electron therapy
3. Radiation: low-LET photon therapy

Primary outcomes (0)

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Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Microscopically confirmed solid tumor or lymphoma not potentially curable by conventional surgery or radiotherapy
* Previously unirradiated disease scheduled to receive thoracic irradiation of up to 60 Gy, including pulmonary and esophageal tumors
* No metastatic disease more effectively treated by systemic chemotherapy
* No history of brain metastases

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: ECOG 0 or 1
* WBC at least 4,000
* ANC at least 1,500
* Platelets at least 100,000
* Bilirubin no greater than 1.5 mg/dL
* Creatinine no greater than 1.5 mg/dL
* Calcium no greater than 11.0 mg/dL
* No pregnant or nursing women
* Pregnancy test required, as appropriate
* Effective contraception required of fertile patient

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since chemotherapy (6 weeks since nitrosoureas and mitomycin) and recovered
* At least 4 weeks since radiotherapy and recovered

References

Publications (1)

RESULTForouzannia A, Schiller J, Berlin J, Hutson P, Boothman D, Storer B, Wilding G, Mehta M. A phase I study of Topotecan, as a radiosensitizer, for thoracic malignancies. Lung Cancer. 2004 Apr;44(1):111-9. doi: 10.1016/j.lungcan.2003.10.005. PMID 15013589

Registry

Dates and enrollment